Application 090509

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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 1.

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
A090509-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090509-001	AB
A090509-002	AB
A090509-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090509-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Major Pharmaceuticals	0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509 ndc (product): 0904-6624 ndc (product): 0904-6623
Tacrolimus	TACROLIMUS	Quallent Pharmaceuticals Health LLC	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	American Health Packaging	93d03943-0655-44f6-b494-57bd1e336a34	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509 ndc (product): 68084-449 ndc (product): 68084-450 ndc (product): 68084-451
Tacrolimus	TACROLIMUS	Dr. Reddy's Laboratories Limited	61dee012-43af-0e9a-3843-9b9b91e022c4	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509 ndc (product): 55111-526 ndc (product): 55111-525 ndc (product): 55111-527

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6623	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6623	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6623	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6624	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6624	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
0904-6624	Tacrolimus	Tacrolimus	Major Pharmaceuticals	ANDA	Current
55111-525	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-525	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-525	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-525	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-526	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-526	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-526	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-526	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-527	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-527	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-527	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-527	Tacrolimus	Tacrolimus	Dr. Reddy's Laboratories Limited	ANDA	Current
68084-449	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-449	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-449	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-449	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-450	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-450	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-450	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-450	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-451	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-451	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-451	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current
68084-451	Tacrolimus	Tacrolimus	American Health Packaging	ANDA	Current