Tacrolimus

Product NDC: 0378-2046
11-digit product format: 003782046
Labeler code: 0378
Product ID: 0378-2046_7d8a5bab-a744-4aa7-b28f-d0c2c5a53628
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090596
Marketing category: ANDA
Marketing start: 2010-09-17
Substance: TACROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A090596-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17
A090596-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17
A090596-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090596-001	AB
A090596-002	AB
A090596-003	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 · 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	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`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	A090596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090596-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090596-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090596-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tacrolimus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	1 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
198377	Internal RxNorm lookup
198378	Internal RxNorm lookup
313190	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
45af3eda-caaa-4478-9372-95aa65adc9b3	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
0378-2046-01	Tacrolimus	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2046-01	EA - Each	0378-2046	5a0643a1-7a94-411d-90ab-2a4929f27eb8	1	2012-07-24
0378-2046-05	EA - Each	0378-2046	e126af7a-a9ce-45b0-89d8-9e67f44ed714	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	4
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TACROLIMUS CAPSULE [MYLAN INSTITUTIONAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2046	TACROLIMUS CAPSULE [MYLAN PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 1 package rows	20250328_45af3eda-caaa-4478-9372-95aa65adc9b3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Safecor Health LLC	393cd10e-133c-4d6b-b024-270eb82edbb3	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596
Tacrolimus	TACROLIMUS	Golden State Medical Supply, Inc.	34ec4989-6933-4237-ae1e-50a0cb90a2fe	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596
Tacrolimus	TACROLIMUS	Mylan Pharmaceuticals Inc.	45af3eda-caaa-4478-9372-95aa65adc9b3	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 0378-2046
Tacrolimus	TACROLIMUS	MylanInstitutional Inc.	5f742224-618e-4f4c-bdec-7693be99c697	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596
Tacrolimus	TACROLIMUS	Aphena Pharma Solutions - Tennessee, LLC	4caa20af-45a8-4365-9f06-1568afae61b1	2017-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596

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
313190	tacrolimus 0.5 MG Oral Capsule	PSN	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198377	tacrolimus 1 MG Oral Capsule	PSN	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198378	tacrolimus 5 MG Oral Capsule	PSN	45af3eda-caaa-4478-9372-95aa65adc9b3	22
313190	tacrolimus 0.5 MG Oral Capsule	SCD	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198377	tacrolimus 1 MG Oral Capsule	SCD	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198378	tacrolimus 5 MG Oral Capsule	SCD	45af3eda-caaa-4478-9372-95aa65adc9b3	22
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	45af3eda-caaa-4478-9372-95aa65adc9b3	22
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	45af3eda-caaa-4478-9372-95aa65adc9b3	22
313190	tacrolimus 0.5 MG Oral Capsule	PSN	5f742224-618e-4f4c-bdec-7693be99c697	18
198377	tacrolimus 1 MG Oral Capsule	PSN	5f742224-618e-4f4c-bdec-7693be99c697	18
198378	tacrolimus 5 MG Oral Capsule	PSN	5f742224-618e-4f4c-bdec-7693be99c697	18
313190	tacrolimus 0.5 MG Oral Capsule	SCD	5f742224-618e-4f4c-bdec-7693be99c697	18
198377	tacrolimus 1 MG Oral Capsule	SCD	5f742224-618e-4f4c-bdec-7693be99c697	18
198378	tacrolimus 5 MG Oral Capsule	SCD	5f742224-618e-4f4c-bdec-7693be99c697	18
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	5f742224-618e-4f4c-bdec-7693be99c697	18
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	5f742224-618e-4f4c-bdec-7693be99c697	18
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	5f742224-618e-4f4c-bdec-7693be99c697	18
313190	tacrolimus 0.5 MG Oral Capsule	PSN	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198377	tacrolimus 1 MG Oral Capsule	PSN	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198378	tacrolimus 5 MG Oral Capsule	PSN	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
313190	tacrolimus 0.5 MG Oral Capsule	SCD	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198377	tacrolimus 1 MG Oral Capsule	SCD	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198378	tacrolimus 5 MG Oral Capsule	SCD	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	34ec4989-6933-4237-ae1e-50a0cb90a2fe	13
313190	tacrolimus 0.5 MG Oral Capsule	PSN	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198377	tacrolimus 1 MG Oral Capsule	PSN	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198378	tacrolimus 5 MG Oral Capsule	PSN	393cd10e-133c-4d6b-b024-270eb82edbb3	3
313190	tacrolimus 0.5 MG Oral Capsule	SCD	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198377	tacrolimus 1 MG Oral Capsule	SCD	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198378	tacrolimus 5 MG Oral Capsule	SCD	393cd10e-133c-4d6b-b024-270eb82edbb3	3
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	393cd10e-133c-4d6b-b024-270eb82edbb3	3
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	393cd10e-133c-4d6b-b024-270eb82edbb3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2046-01	00378204601	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2046-01)	100 capsule	2010-09-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tacrolimus	Safecor Health LLC	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	3
Tacrolimus	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	13
Tacrolimus	Mylan Pharmaceuticals Inc.	2025-08-15	HUMAN PRESCRIPTION DRUG LABEL	22
Tacrolimus	MylanInstitutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	18