Tacrolimus

Product NDC: 0781-9304
11-digit product format: 007819304
Labeler code: 0781
Product ID: 0781-9304_9d5be1ff-0d4e-47a8-92f4-6a359e623045
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065461
Marketing category: ANDA
Marketing start: 2012-01-15
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: 2019-12-31
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	0781-9304		D	Discontinued by firm		2026-08-17
excluded package	package	0781-9304	0781-9304-01	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-9304-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-9304-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-9304-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-9304-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-9304-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-9304-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-9304-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-9304-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-9304-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-9304-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-9304-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-9304-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-9304-01	EA - Each	0781-9304	910b8dcc-d6e0-4914-8b69-b4e52102a408	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	TACROLIMUS CAPSULE [SANDOZ INC]	6
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	TACROLIMUS CAPSULE [SANDOZ INC]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TACROLIMUS CAPSULE [SANDOZ INC]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TACROLIMUS CAPSULE [SANDOZ INC]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TACROLIMUS CAPSULE [SANDOZ INC]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TACROLIMUS CAPSULE [SANDOZ INC]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TACROLIMUS CAPSULE [SANDOZ INC]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TACROLIMUS CAPSULE [SANDOZ INC]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TACROLIMUS CAPSULE [SANDOZ INC]	6
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	TACROLIMUS CAPSULE [SANDOZ INC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TACROLIMUS CAPSULE [SANDOZ INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TACROLIMUS CAPSULE [SANDOZ INC]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TACROLIMUS CAPSULE [SANDOZ INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TACROLIMUS CAPSULE [SANDOZ INC]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TACROLIMUS CAPSULE [SANDOZ INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TACROLIMUS CAPSULE [SANDOZ INC]	6

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
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