Tacrolimus

Product NDC: 70518-3216
Requested package NDC: 70518-3216-0
11-digit product format: 705183216
Labeler code: 70518
Product ID: 70518-3216_cbe11b6a-8dae-3648-e053-2a95a90a3573
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA091195
Marketing category: ANDA
Marketing start: 2021-09-09
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3216	70518-3216-0	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 · 11 matching rows.

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

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

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
A091195-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31
A091195-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31
A091195-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091195-001	BX
A091195-002	BX
A091195-003	BX

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	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`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	A091195-001	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-002	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-003	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091195-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091195-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091195-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091195-001	BX	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3216-0	2023-03-21	C162847	48780-1	f386c64a-015f-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
70518-3216-0	2023-01-30	C162847	48780-1	f386c64a-015f-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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	a2e55495-10cc-4f6e-b866-1e7d6e45888b	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195
Tacrolimus	TACROLIMUS	Accord Healthcare Inc.	bd447ffa-9196-4c3c-accf-5adf29b84665	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195

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	Marketing end	Sample	Exclude flag	Status
70518-3216-0	70518321600	100 POUCH in 1 BOX (70518-3216-0) > 1 CAPSULE in 1 POUCH (70518-3216-1)	100 pouch	2021-09-09	0000-00-00	No	No	Current