Tacrolimus

Product NDC: 82804-032
11-digit product format: 828040032
Labeler code: 82804
Product ID: 82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA065461
Marketing category: ANDA
Marketing start: 2009-08-10
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 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
A065461-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10
A065461-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10
A065461-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065461-001	AB
A065461-002	AB
A065461-003	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	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065461-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2009-08-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065461-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065461-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065461-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065461-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065461-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065461-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065461-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065461-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065461-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065461-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065461-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065461-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065461-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065461-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065461-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065461-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065461-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065461-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065461-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065461-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065461-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065461-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065461-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065461-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065461-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065461-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065461-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065461-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065461-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065461-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065461-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065461-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065461-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065461-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065461-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065461-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065461-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065461-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065461-002	AB	1	`3f01610625f2…`

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198377	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
20d1c12a-bf4b-4467-93a0-ee8b892abea9	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	SPL version
82804-032-30	Tacrolimus	30 in 1 BOTTLE	CAPSULE	30	1
82804-032-60	Tacrolimus	60 in 1 BOTTLE	CAPSULE	60	1
82804-032-90	Tacrolimus	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-032-30	EA - Each	82804-032	d1f04c33-74ff-44b0-a5ad-165210c2ef3c	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-032	TACROLIMUS CAPSULE [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20231027_20d1c12a-bf4b-4467-93a0-ee8b892abea9.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	f21115e2-1d02-4bce-9c13-bf593a52a12f	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	3dc347e3-9bfd-4910-adb5-24e979208345	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	27154d3a-eec5-4000-a4ff-bfbfe27eb806	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	976f1b69-dd96-4815-b11b-839ce1c45633	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	A-S Medication Solutions	98e0584d-16d2-442b-86ce-e5e65239db0c	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Direct_Rx	10ceb3bc-11cc-13e4-e063-6394a90acce4	2024-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461
Tacrolimus	TACROLIMUS	Proficient Rx LP	20d1c12a-bf4b-4467-93a0-ee8b892abea9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461 ndc (product): 82804-032

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	20d1c12a-bf4b-4467-93a0-ee8b892abea9	1
198377	tacrolimus 1 MG Oral Capsule	SCD	20d1c12a-bf4b-4467-93a0-ee8b892abea9	1
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	20d1c12a-bf4b-4467-93a0-ee8b892abea9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-032-30	82804003230	30 CAPSULE in 1 BOTTLE (82804-032-30)	30 capsule	2023-10-25	No	No	Current
82804-032-60	82804003260	60 CAPSULE in 1 BOTTLE (82804-032-60)	60 capsule	2023-10-25	No	No	Current
82804-032-90	82804003290	90 CAPSULE in 1 BOTTLE (82804-032-90)	90 capsule	2023-10-25	No	No	Current