Application 065461

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 0.5MG BASE	No	No
002	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 1MG BASE	No	No
003	TACROLIMUS	TACROLIMUS	CAPSULE;ORAL	EQ 5MG BASE	No	No

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

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Sandoz Inc.	46ac55cf-d85e-4c34-bb33-f49e078c4a03	2025-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065461 application number: ANDA065461 ndc (product): 0781-2102 ndc (product): 0781-2103 ndc (product): 0781-2104
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 ndc (product): 63629-8725
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 ndc (product): 63629-8723
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 ndc (product): 63629-8726
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 ndc (product): 50090-5596
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 Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2102	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2102	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2102	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2102	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2102	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2103	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2103	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2103	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2103	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2103	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2104	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2104	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2104	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2104	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-2104	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-9302	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-9303	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
0781-9304	Tacrolimus	Tacrolimus	Sandoz Inc	ANDA	Current
50090-5596	Tacrolimus	Tacrolimus	A-S Medication Solutions	ANDA	Current
55154-5438	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
63629-8723	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
63629-8723	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
63629-8725	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
63629-8725	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
63629-8726	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
63629-8726	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
70518-2593	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2593	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2593	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
72572-760	Tacrolimus	Tacrolimus	Civica, Inc.	ANDA	Current
72572-760	Tacrolimus	Tacrolimus	Civica, Inc.	ANDA	Current
72572-761	Tacrolimus	Tacrolimus	Civica, Inc.	ANDA	Current
72572-761	Tacrolimus	Tacrolimus	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42818	ORIG	2011-12-02
30664	ORIG	2009-08-14
18338	ORIG	2009-08-13