Tacrolimus

Product NDC: 50268-737
11-digit product format: 502680737
Labeler code: 50268
Product ID: 50268-737_5bf16999-e946-d4c5-e063-6394a90aa389
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA090509
Marketing category: ANDA
Marketing start: 2026-09-20
Substance: TACROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090509-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090509-001	AB
A090509-002	AB
A090509-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090509-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090509-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090509-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090509-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090509-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090509-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tacrolimus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	1 mg/1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Major Pharmaceuticals	0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	Quallent Pharmaceuticals Health LLC	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	American Health Packaging	93d03943-0655-44f6-b494-57bd1e336a34	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	Dr. Reddy's Laboratories Limited	61dee012-43af-0e9a-3843-9b9b91e022c4	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WM0HAQ4WNM	TACROLIMUS	109581-93-3	TACROLIMUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-737-15	50268073715	50 BLISTER PACK in 1 BOX (50268-737-15) / 1 CAPSULE in 1 BLISTER PACK (50268-737-11)	50 blister pack	2026-09-20	No	No	Current