Tacrolimus

Product NDC: 69238-2780
11-digit product format: 692382780
Labeler code: 69238
Product ID: 69238-2780_05c70395-3037-4e8a-be20-dd9f4aebbe06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA215012
Marketing category: ANDA
Marketing start: 2026-03-02
Substance: TACROLIMUS
Active strength: .5 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215012-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25
A215012-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25
A215012-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215012-001	AB
A215012-002	AB
A215012-003	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 2 · 57 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
2026-09-14 22:38:34	2026-08	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-002	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-003	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215012-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-01-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215012-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215012-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215012-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215012-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215012-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215012-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215012-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215012-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215012-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215012-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215012-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215012-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215012-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215012-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215012-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215012-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215012-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215012-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215012-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215012-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215012-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215012-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215012-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215012-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tacrolimus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	.5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1431971	Internal RxNorm lookup
1431980	Internal RxNorm lookup
1431985	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
4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-2780-3	Tacrolimus	3 in 1 BAG	CAPSULE, EXTENDED RELEASE	3		1
69238-2780-3	Tacrolimus	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1		1

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	Amneal Pharmaceuticals NY LLC	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215012 application number: ANDA215012 ndc (product): 69238-2780
tacrolimus	TACROLIMUS EXTENDED-RELEASE CAPSULES	Chengdu Suncadia Medicine Co., Ltd.	08cf2861-2483-405d-a872-a88a5c235f9a	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215012 application number: ANDA215012

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
1431971	tacrolimus 0.5 MG 24HR Extended Release Oral Capsule	PSN	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431980	tacrolimus 1 MG 24HR Extended Release Oral Capsule	PSN	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431985	tacrolimus 5 MG 24HR Extended Release Oral Capsule	PSN	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431971	24 HR tacrolimus 0.5 MG Extended Release Oral Capsule	SCD	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431980	24 HR tacrolimus 1 MG Extended Release Oral Capsule	SCD	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431985	24 HR tacrolimus 5 MG Extended Release Oral Capsule	SCD	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431971	tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431980	tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1
1431985	tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69238-2780-3	69238278003	1 BAG in 1 CARTON (69238-2780-3) / 3 BLISTER PACK in 1 BAG / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	1 bag	2026-03-02	No	No	Current