Application 090034

Type: ANDA
Sponsor: LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIFAMPIN	RIFAMPIN	CAPSULE;ORAL	150MG	No	No
002	RIFAMPIN	RIFAMPIN	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090034-001	RIFAMPIN	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21
A090034-002	RIFAMPIN	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090034-001	AB
A090034-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB		2013-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090034-001	RIFAMPIN	150MG	CAPSULE / ORAL	AB		2013-08-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090034-002	RIFAMPIN	300MG	CAPSULE / ORAL	AB	RS	2013-08-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090034-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090034-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090034-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090034-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090034-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090034-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090034-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090034-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090034-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090034-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090034-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090034-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090034-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090034-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090034-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090034-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090034-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090034-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090034-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090034-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090034-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090034-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090034-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090034-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090034-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090034-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090034-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090034-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090034-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090034-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090034-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090034-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090034-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090034-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090034-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090034-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090034-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090034-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090034-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090034-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
rifampin	RIFAMPIN	Bryant Ranch Prepack	0cb75e95-d165-4580-9340-42d7a9fd546e	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090034 application number: ANDA090034
rifampin	RIFAMPIN	Major Pharmaceuticals	3f3534c1-95e4-4bdd-b044-9026e4addf0c	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090034 application number: ANDA090034
rifampin	RIFAMPIN	Lupin Pharmaceuticals, Inc.	b56004f0-f23d-47f6-80c7-39884fccbccc	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090034 application number: ANDA090034 ndc (product): 68180-658 ndc (product): 68180-659
rifampin	RIFAMPIN	A-S Medication Solutions	d53b6998-6e3b-4c6f-8465-2af6897d1efe	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090034 application number: ANDA090034 ndc (product): 50090-5709
Rifampin	RIFAMPIN	American Health Packaging	50f706f9-5003-4e15-bece-85b6213b1f5c	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090034 application number: ANDA090034 ndc (product): 60687-586 ndc (product): 60687-575

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5709	rifampin	rifampin	A-S Medication Solutions	ANDA	Current
60687-575	Rifampin	Rifampin	American Health Packaging	ANDA	Current
60687-575	Rifampin	Rifampin	American Health Packaging	ANDA	Current
60687-586	Rifampin	Rifampin	American Health Packaging	ANDA	Current
60687-586	Rifampin	Rifampin	American Health Packaging	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, In	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-658	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, In	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-659	rifampin	rifampin	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2404	rifampin	rifampin	REMEDYREPACK INC.	ANDA	Current
70518-2404	rifampin	rifampin	REMEDYREPACK INC.	ANDA	Current
70518-2404	rifampin	rifampin	REMEDYREPACK INC.	ANDA	Current
70518-2404	rifampin	rifampin	REMEDYREPACK INC.	ANDA	Current
70518-3199	rifampin	rifampin	REMEDYREPACK INC.	ANDA	Current