Tacrolimus

Product NDC: 62250-667
11-digit product format: 622500667
Labeler code: 62250
Product ID: 62250-667_efe342f9-9a69-b9b4-e053-2a95a90a3e00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus Capsules
Dosage form: CAPSULE
Route: ORAL
Labeler: Belcher Pharmaceuticals,LLC
Application: ANDA206651
Marketing category: ANDA
Marketing start: 2018-04-25
Marketing end: 0000-00-00
Substance: TACROLIMUS
Active strength: 5 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62250-667		I	Inactivated by FDA		2026-08-17
excluded package	package	62250-667	62250-667-02	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62250-667-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62250-667-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62250-667-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62250-667-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62250-667-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62250-667-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62250-667-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62250-667-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62250-667-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A206651-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30
A206651-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30
A206651-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206651-001	AB
A206651-002	AB
A206651-003	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	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2017-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206651-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2017-11-30	`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	A206651-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206651-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206651-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206651-001	AB	1	`1e350fbaab3a…`

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
62250-667-02	2025-01-30	C162847	48780-1	2cef2736-59af-d83d-e063-dadaa90ab31f	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
62250-667-02	Tacrolimus	100 in 1 BOTTLE	CAPSULE	100		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62250-667	TACROLIMUS CAPSULE TACROLIMUS (TACROLIMUS CAPSULES) CAPSULE [BELCHER PHARMACEUTICALS,LLC]	9	Legacy NDC, 1 package rows	20231006_bf191c03-3e4b-4b45-a0d2-47809a847af6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	BPI Labs LLC	3e8bc65e-8048-4073-8e45-570330603000	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206651 application number: ANDA206651
Tacrolimus	TACROLIMUS	Ajenat Pharmaceuticals LLC	ca08d4aa-3de2-4a9d-9554-6288e5d36f29	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206651 application number: ANDA206651

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
313190	tacrolimus 0.5 MG Oral Capsule	PSN	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198377	tacrolimus 1 MG Oral Capsule	PSN	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198378	tacrolimus 5 MG Oral Capsule	PSN	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
313190	tacrolimus 0.5 MG Oral Capsule	SCD	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198377	tacrolimus 1 MG Oral Capsule	SCD	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198378	tacrolimus 5 MG Oral Capsule	SCD	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	bf191c03-3e4b-4b45-a0d2-47809a847af6	9
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	bf191c03-3e4b-4b45-a0d2-47809a847af6	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62250-667-02	62250066702	100 CAPSULE in 1 BOTTLE (62250-667-02)	100 capsule	2018-04-25	0000-00-00	No	No	Current