RIFAMPIN

Product NDC: 0904-5282
Requested package NDC: 0904-5282-61
11-digit product format: 009045282
Labeler code: 0904
Product ID: 0904-5282_ac10a90f-a26d-457f-96dd-1825d04a6719
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RIFAMPIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA064150
Marketing category: ANDA
Marketing start: 2009-10-07
Marketing end: 2023-12-31
Substance: RIFAMPIN
Active strength: 300 mg/1
Pharmacologic classes: Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5282	0904-5282-61	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A064150-001	RIFAMPIN	RIFAMPIN	300MG	CAPSULE / ORAL	AB		1997-05-28
A064150-002	RIFAMPIN	RIFAMPIN	150MG	CAPSULE / ORAL	AB		1998-01-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064150-001	AB
A064150-002	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 · 84 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	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064150-001	RIFAMPIN	300MG	CAPSULE / ORAL	AB	1997-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064150-002	RIFAMPIN	150MG	CAPSULE / ORAL	AB	1998-01-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A064150-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064150-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064150-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064150-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064150-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064150-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064150-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064150-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064150-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064150-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064150-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064150-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064150-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064150-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064150-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064150-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064150-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064150-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064150-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064150-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064150-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064150-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064150-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064150-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064150-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064150-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064150-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064150-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064150-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5282-06	EA - Each	0904-5282	8fa5831a-5c4f-47a2-b2fb-a6bfbad51e5b	1	2012-07-24
0904-5282-61	EA - Each	0904-5282	aa2e80d6-7e74-4df1-88c2-fd60ccc1bb15	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIFAMPIN	ACTIVE INGREDIENT	VJT6J7R4TR	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
RIFAMPIN	ACTIVE MOIETY	VJT6J7R4TR	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS]	5

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
RIFAMPIN	RIFAMPIN	Coupler LLC	410a314f-83bf-d9b3-e063-6294a90a872c	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064150 application number: ANDA064150
RIFAMPIN	RIFAMPIN	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	28109dee-3e5e-492b-b7d9-9ba46c0b5324	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064150 application number: ANDA064150
RIFAMPIN	RIFAMPIN	EPIC PHARMA, LLC	0391f1e1-70d4-4b15-8b58-055bb6a385b8	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064150 application number: ANDA064150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VJT6J7R4TR	RIFAMPIN	13292-46-1	RIFAMPIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5282-61	00904528261	100 BLISTER PACK in 1 CARTON (0904-5282-61) > 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2009-10-07	2023-12-31	No	No	Current