Tacrolimus

Product NDC: 55154-4168
11-digit product format: 551544168
Labeler code: 55154
Product ID: 55154-4168_6ee05111-8467-41c9-857f-5a805ce7490b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA090687
Marketing category: ANDA
Marketing start: 2014-08-13
Substance: TACROLIMUS
Active strength: 1 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 44.

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
A090687-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22
A090687-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22
A090687-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090687-001	AB
A090687-002	AB
A090687-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090687-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090687-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090687-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2014-07-22	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090687-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090687-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090687-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090687-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090687-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090687-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090687-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090687-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090687-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090687-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090687-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090687-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090687-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090687-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090687-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090687-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090687-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090687-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090687-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090687-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090687-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090687-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090687-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090687-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090687-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090687-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090687-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090687-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090687-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090687-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090687-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090687-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090687-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090687-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090687-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090687-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090687-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090687-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090687-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090687-002	AB	1	`c0c555d07b60…`

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	1 mg/1

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
55154-4168-0	Tacrolimus	1 in 1 BLISTER PACK	CAPSULE	1		3
55154-4168-0	Tacrolimus	10 in 1 BAG	CAPSULE	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-4168	TACROLIMUS CAPSULE [CARDINAL HEALTH 107, LLC]	2	Current NDC, 2 package rows	20240629_450c3e32-6d91-4508-b064-49b293e86cec.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	Major Pharmaceuticals	213f6047-f897-48a7-b78a-45d7124f2f16	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090687 application number: ANDA090687
Tacrolimus	TACROLIMUS	Strides Pharma Science Limited	ed7d1495-3585-409d-94f1-b3d2469d222c	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090687 application number: ANDA090687

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
198377	tacrolimus 1 MG Oral Capsule	PSN	450c3e32-6d91-4508-b064-49b293e86cec	3
198377	tacrolimus 1 MG Oral Capsule	SCD	450c3e32-6d91-4508-b064-49b293e86cec	3
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	450c3e32-6d91-4508-b064-49b293e86cec	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-4168-0	55154416800	10 BLISTER PACK in 1 BAG (55154-4168-0) / 1 CAPSULE in 1 BLISTER PACK	10 blister pack	2014-08-13	No	No	Current