Rifampin

Product NDC: 76420-060
11-digit product format: 764200060
Labeler code: 76420
Product ID: 76420-060_b1aea89e-52fb-b32e-e053-2995a90a032b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rifampin
Dosage form: CAPSULE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA064150
Marketing category: ANDA
Marketing start: 1997-05-28
Marketing end: 0000-00-00
Substance: RIFAMPIN
Active strength: 300 mg/1
Pharmacologic classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76420-060		D	Discontinued by firm	2026-08-17
excluded package	package	76420-060	76420-060-14	D	Discontinued by firm	2026-08-17
excluded package	package	76420-060	76420-060-30	D	Discontinued by firm	2026-08-17
excluded package	package	76420-060	76420-060-60	D	Discontinued by firm	2026-08-17

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-060	RIFAMPIN CAPSULE [ASCLEMED USA, INC.]	1	Legacy NDC	20201015_e7b0571a-1bb8-45be-94cd-3539d314af69.zip

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
76420-060-14	76420006014	14 CAPSULE in 1 BOTTLE (76420-060-14)	14 capsule	2020-10-15	0000-00-00	No	No	Current
76420-060-30	76420006030	30 CAPSULE in 1 BOTTLE (76420-060-30)	30 capsule	2020-10-15	0000-00-00	No	No	Current
76420-060-60	76420006060	60 CAPSULE in 1 BOTTLE (76420-060-60)	60 capsule	2020-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rifampin Capsules, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-10-14	HUMAN PRESCRIPTION DRUG LABEL	1