Tacrolimus

Product NDC: 50090-5596
11-digit product format: 500905596
Labeler code: 50090
Product ID: 50090-5596_2fd588a9-974c-49a1-906d-b3d890607c48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065461
Marketing category: ANDA
Marketing start: 2009-08-10
Substance: TACROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065461-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10
A065461-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10
A065461-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065461-001	AB
A065461-002	AB
A065461-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065461-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065461-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065461-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065461-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065461-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tacrolimus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WM0HAQ4WNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198377	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98e0584d-16d2-442b-86ce-e5e65239db0c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
df369ad4-19d8-393a-de46-8c6255b8b360	Product name	8	20251120
d2a74186-7b26-dbcc-9435-50b3d0be14ab	Product name	2	20250114
a64835ae-fa9d-41d8-9a93-36828ba72b96	Product name	3	20190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8bad	Product name	1	20150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5596-0	2023-02-07	C162847	48780-1	f386c649-f336-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994
50090-5596-0	2023-01-30	C162847	48780-1	f386c649-f336-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5596-0	Tacrolimus	90 in 1 BOTTLE	CAPSULE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5596-0	EA - Each	50090-5596	ad126fbe-a2b1-4424-ac30-0e0c290895fc	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5596	TACROLIMUS CAPSULE [A-S MEDICATION SOLUTIONS]	7	Current NDC, Legacy NDC, 1 package rows	20240719_98e0584d-16d2-442b-86ce-e5e65239db0c.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Sandoz Inc.	46ac55cf-d85e-4c34-bb33-f49e078c4a03	2025-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	f21115e2-1d02-4bce-9c13-bf593a52a12f	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	3dc347e3-9bfd-4910-adb5-24e979208345	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	27154d3a-eec5-4000-a4ff-bfbfe27eb806	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	976f1b69-dd96-4815-b11b-839ce1c45633	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	A-S Medication Solutions	98e0584d-16d2-442b-86ce-e5e65239db0c	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461 ndc (product): 50090-5596
Tacrolimus	TACROLIMUS	Direct_Rx	10ceb3bc-11cc-13e4-e063-6394a90acce4	2024-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Proficient Rx LP	20d1c12a-bf4b-4467-93a0-ee8b892abea9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198377	tacrolimus 1 MG Oral Capsule	PSN	98e0584d-16d2-442b-86ce-e5e65239db0c	7
198377	tacrolimus 1 MG Oral Capsule	SCD	98e0584d-16d2-442b-86ce-e5e65239db0c	7
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	98e0584d-16d2-442b-86ce-e5e65239db0c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5596-0	50090559600	90 CAPSULE in 1 BOTTLE (50090-5596-0)	90 capsule	2021-07-23	0000-00-00	No	No	Current