rifampin

Product NDC: 70518-3199
Requested package NDC: 70518-3199-0
11-digit product format: 705183199
Labeler code: 70518
Product ID: 70518-3199_ca3aa7a8-9d27-3d66-e053-2a95a90a05be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rifampin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090034
Marketing category: ANDA
Marketing start: 2021-08-21
Marketing end: 0000-00-00
Substance: RIFAMPIN
Active strength: 150 mg/1
Pharmacologic classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3199	70518-3199-0	D	Discontinued by firm		2026-08-03

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 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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3199-0	2023-03-21	C162847	48780-1	f386c649-c79e-0266-e053-dadaa90a7c1a	Rifampin Capsules USP
70518-3199-0	2023-01-30	C162847	48780-1	f386c649-c79e-0266-e053-dadaa90a7c1a	Rifampin Capsules USP

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
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
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

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
70518-3199-0	70518319900	30 CAPSULE in 1 BLISTER PACK (70518-3199-0)	30 capsule	2021-08-21	0000-00-00	No	No	Current