Application 212297

Type: ANDA
Sponsor: BIOCON PHARMA

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
A212297-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10
A212297-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10
A212297-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212297-001	AB
A212297-002	AB
A212297-003	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 3 · 111 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	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212297-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-11-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A212297-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212297-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212297-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212297-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212297-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212297-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212297-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212297-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212297-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212297-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212297-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212297-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212297-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212297-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212297-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212297-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212297-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212297-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212297-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212297-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212297-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212297-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Cardinal Health 107, LLC	e898ee90-faae-42a8-b652-be1c8730d856	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212297 application number: ANDA212297 ndc (product): 55154-4080
Tacrolimus	TACROLIMUS	Biocon Pharma Inc.	0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f	2023-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212297 application number: ANDA212297 ndc (product): 70377-014 ndc (product): 70377-016 ndc (product): 70377-015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55154-4080	Tacrolimus	Tacrolimus	Cardinal Health 107, LLC	ANDA	Current
55154-4080	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
70377-014	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-014	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-014	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-015	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-015	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-015	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-016	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-016	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70377-016	Tacrolimus	Tacrolimus	Biocon Pharma Inc.	ANDA	Current
70518-2996	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current
70518-3022	Tacrolimus	Tacrolimus	REMEDYREPACK INC.	ANDA	Current