Tacrolimus

Product NDC: 70748-220
Requested package NDC: 70748-220-01
11-digit product format: 707480220
Labeler code: 70748
Product ID: 70748-220_aa103517-d680-43f0-9437-2820764d95f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA213112
Marketing category: ANDA
Marketing start: 2020-11-23
Marketing end: 0000-00-00
Substance: TACROLIMUS
Active strength: 1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70748-220	70748-220-01	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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A213112-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10
A213112-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10
A213112-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213112-001	AB
A213112-002	AB
A213112-003	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 3 · 111 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	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213112-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213112-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213112-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2020-11-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A213112-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213112-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213112-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213112-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213112-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213112-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213112-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213112-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213112-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213112-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213112-003	AB	1	`5c6f7cd8ea54…`

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	Stellon Biotech Inc.	6b89e8a4-9f11-42e3-8e79-fe617e7c461f	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213112 application number: ANDA213112
Tacrolimus	TACROLIMUS	CONCORD BIOTECH LIMITED	823b11cb-d873-4017-a861-d22d2c5a8a49	2023-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213112 application number: ANDA213112

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
70748-220-01	70748022001	100 CAPSULE in 1 BOTTLE (70748-220-01)	100 capsule	2020-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tacrolimus	Lupin Pharmaceuticals, Inc. \| CONCORD BIOTECH LIMITED	2022-08-31	HUMAN PRESCRIPTION DRUG LABEL	5