FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Tacrolimus Capsules
Status: Currently in Shortage
»Date first posted: 05/17/2019
»Therapeutic Categories: Transplant

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Accord Healthcare Inc. (Reverified 02/17/2021)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count (NDC 1672904101) Limited supply availability. Product will be allocated until Q3 2021 Limited API availability
1 mg 100 count (NDC 1672904201) Limited supply availability. Product will be allocated until Q3 2021 Limited API availability
5 mg 100 count (NDC 1672904301) Product is available

Ascend Laboratories LLC. (New 01/26/2021)

Company Contact Information:
860-667-7081

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100’s count (NDC 67877-278-01) Available
0.5mg 5x10’s UD pack (NDC 67877-278-33) Currently, this configuration is not available Catering to 100’s count pack requirement.
1 mg 100’s count (NDC 67877-279-01) Available
1 mg 5x10’s UD pack (NDC 67877-279-33) Currently, this configuration is not available Catering to 100’s count pack requirement.
5 mg 100’s count (NDC 67877-280-01) Available
5mg 5x10’s UD pack (NDC 67877-280-33) Currently, this configuration is not available Catering to 100’s count pack requirement .

Astellas (Reverified 01/21/2021)

Company Contact Information:
800-727-7003

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
PROGRAF® (tacrolimus) capsules 0.5 mg 100 count bottle (NDC 0469-0607-73) Available
PROGRAF® (tacrolimus) capsules 5 mg 100 count bottle (NDC 0469-0657-73) Available
PROGRAF® (tacrolimus) capsules 1 mg 100 count bottle (NDC 0469-0617-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 0.5 mg 30 count bottle (NDC 0469-0647-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 1 mg 30 count bottle (NDC 0469-0677-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 5 mg 30 count bottle (NDC 0469-0687-73) Available
PROGRAF® Granules (tacrolimus for oral suspension) 0.2 mg unit dose packets (NDC 0469-1230-50) Available
PROGRAF® Granules (tacrolimus for oral suspension) 1 mg unit dose packets (NDC 0469-1330-50) Available

BPI Labs, LLC (Reverified 01/25/2021)

Company Contact Information:
727-471-0850 ext. 275

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottle (NDC 54288-135-01) Available

Dr. Reddy's Laboratories, Inc. (Revised 03/29/2021)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg (NDC 55111-525-01) Available
1 mg (NDC 55111-526-01) Available
5 mg (NDC 55111-527-01) Available

Glenmark Pharmaceuticals (New 01/13/2021)

Company Contact Information:
888-721-7115

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count bottles (NDC 68462-685-01) Currently limited with full availability anticipated in March 2021 Shortage of an active ingredient
1 mg 100 count bottles (NDC 68462-686-01) Currently limited with full availability anticipated in March 2021 Shortage of an active ingredient
5 mg 100 count bottles (NDC 68462-687-01) Anticipated availability - April 2021 Shortage of an active ingredient

Mylan Pharmaceuticals Inc. (Reverified 04/13/2021)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg, 100s (NDC 0378-2045-01) Available
1 mg, 100s (NDC 0378-2046-01) Available
5 mg, 100s (NDC 0378-2047-01) Available

Sandoz (Reverified 04/15/2021)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count bottle (NDC 0781-2102-01) Available Demand increase for the drug
1 mg 100 count bottle (NDC 0781-2103-04) Available Demand increase for the drug
5 mg 100 count bottle (NDC 0781-2104-01) Available Demand increase for the drug

Strides Pharma Inc. (Reverified 03/03/2021)

Company Contact Information:
855-273-0146

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottles (NDC 64338-721-06) Available
0.5 mg 100 count bottles (NDC 64380-720-06) Available
5 mg 100 count bottles (NDC 64380-722-06) Available

Veloxis Pharmaceuticals, Inc. (Reverified 02/03/2021)

Company Contact Information:
919-591-3085

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Envarsus XR 0.75 mg Extended-Release Tablets 30 count (NDC 68992-3075-3) Available
Envarsus XR 0.75 mg Extended-Release Tablets 100 count (NDC 68992-3075-1) Available
Envarsus XR 1 mg Extended-Release Tablets 30 count (NDC 68992-3010-3) Available
Envarsus XR 1 mg Extended-Release Tablets 100 count (NDC 68992-3010-1) Available
Envarsus XR 4 mg Extended-Release Tablets 30 count (NDC 68992-3040-3) Available
Envarsus XR 4 mg Extended-Release Tablets 100 count (NDC 68992-3040-1) Available

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