Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018916
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 1,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/31/1984 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/19/2025 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018916s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018916Orig1s083ltr.pdf | |
| 12/10/2024 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018916Orig1s080ltr.pdf | |
| 10/24/2024 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018916Orig1s079ltr.pdf | |
| 07/30/2020 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018916s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018916Orig1s071ltr.pdf | |
| 07/18/2016 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2016 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf | |
| 04/14/2015 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2015 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2016 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018916Orig1s066,s069ltr.pdf | |
| 01/15/2014 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/2019 | SUPPL-63 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018916Orig1s063, 019339Orig1s052, 019805Orig1s034ltr.pdf | |
| 07/15/2013 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2013 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2013 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018916Orig1s060ltr.pdf | |
| 11/30/2012 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2011 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018916s057ltr.pdf | |
| 11/19/1999 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1997 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/25/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/25/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1992 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1990 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1990 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/23/1989 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 08/21/1987 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/24/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2025 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018916s083lbl.pdf | |
| 12/10/2024 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s080lbl.pdf | |
| 10/24/2024 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s079lbl.pdf | |
| 07/30/2020 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018916s071lbl.pdf | |
| 09/04/2019 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018916s063,019339s052,019805s034lbl.pdf | |
| 04/05/2016 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf | |
| 04/05/2016 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018916s066s069lbl.pdf | |
| 02/12/2013 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018916s060lbl.pdf | |
| 12/23/2011 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018916s057lbl.pdf |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019953 | B BRAUN |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019953 | B BRAUN |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018609 | BAXTER HLTHCARE |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212441 | FRESENIUS KABI USA |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 200 UNITS/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018916 | HOSPIRA |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
There are no Therapeutic Equivalents.
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
There are no Therapeutic Equivalents.