Application 091195

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
A091195-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31
A091195-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31
A091195-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091195-001	BX
A091195-002	BX
A091195-003	BX

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	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091195-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	BX	2011-08-31	`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	A091195-001	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-002	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091195-003	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091195-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091195-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091195-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091195-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091195-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091195-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091195-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091195-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091195-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091195-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091195-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091195-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091195-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091195-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091195-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091195-001	BX	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	a2e55495-10cc-4f6e-b866-1e7d6e45888b	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195 ndc (product): 63629-9325
Tacrolimus	TACROLIMUS	Accord Healthcare Inc.	bd447ffa-9196-4c3c-accf-5adf29b84665	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091195 application number: ANDA091195 ndc (product): 16729-043 ndc (product): 16729-042 ndc (product): 16729-041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6425	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6425	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-041	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-042	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
16729-043	Tacrolimus	Tacrolimus	Accord Healthcare Inc.	ANDA	Current
50090-2245	Tacrolimus	Tacrolimus	A-S Medication Solutions	ANDA	Current
50090-2245	Tacrolimus	Tacrolimus	A-S Medication Solutions	ANDA	Current
55154-2675	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
55154-2675	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
63629-9325	Tacrolimus	Tacrolimus	Bryant Ranch Prepack	ANDA	Current
68788-7331	Tacrolimus	Tacrolimus	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2124	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2124	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2124	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2124	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-2124	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-3216	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current