Tacrolimus

Product NDC: 62175-380
11-digit product format: 621750380
Labeler code: 62175
Product ID: 62175-380_3a86a36e-029d-fded-1f9c-79177d3aaab6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Kremers Urban Pharmaceuticals Inc.
Application: ANDA090802
Marketing category: ANDA
Marketing start: 2015-07-30
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: 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	62175-380		D	Discontinued by firm		2026-10-02
excluded package	package	62175-380	62175-380-37	D	Discontinued by firm		2026-10-02

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 · 42 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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`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	62175-380-37	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62175-380-37	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62175-380-37	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62175-380-37	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62175-380-37	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62175-380-37	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62175-380-37	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62175-380-37	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62175-380-37	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62175-380-37	`9bebd1f3094a…`	`5416666fcb17…`

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
A090802-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28
A090802-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28
A090802-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090802-001	AB
A090802-002	AB
A090802-003	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 · 129 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	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2012-09-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A090802-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090802-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090802-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090802-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090802-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090802-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090802-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090802-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090802-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090802-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090802-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090802-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090802-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090802-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090802-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090802-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62175-380-37	2020-01-31	C162847	48780-1	9d75b9d0-9e4d-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Tacrolimus Capsules USP safely and effectively. See full prescribing information for Tacrolimus Capsules USP. Tacrolimus Capsules USP Initial U.S. Approval 1994 Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62175-380-37	EA - Each	62175-380	60ddcd58-57bd-4091-9bde-a87a22bd8271	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62175-380	TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.]	9	Legacy NDC	20150730_468deb25-1661-5a4e-a6e8-bc5088ac5977.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	Jubilant Cadista Pharmaceuticals Inc.	651bd506-96b0-43e5-a4dd-db03bf9154c9	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090802 application number: ANDA090802
Tacrolimus	TACROLIMUS	Panacea Biotec Limited	bd9fea26-0236-d437-c7df-4b7636210875	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090802 application number: ANDA090802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WM0HAQ4WNM	TACROLIMUS	109581-93-3	TACROLIMUS

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tacrolimus	Kremers Urban Pharmaceuticals Inc. \| Panacea Biotec Ltd \| Panacea Biotec Ltd.	2015-07-30	HUMAN PRESCRIPTION DRUG LABEL	9