Priftin

Product NDC: 0088-2100
11-digit product format: 000882100
Labeler code: 0088
Product ID: 0088-2100_3fdcd209-74fd-4fc6-84ca-944f1fb6ff02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rifapentine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: sanofi-aventis U.S. LLC
Application: NDA021024
Marketing category: NDA
Marketing start: 2009-03-30
Marketing end: 2020-11-30
Substance: RIFAPENTINE
Active strength: 150 mg/1
Pharmacologic classes: Rifamycin Antimycobacterial [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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0088-2100		D	Discontinued by firm	2026-08-03
excluded package	package	0088-2100	0088-2100-24	D	Discontinued by firm	2026-08-03
excluded package	package	0088-2100	0088-2100-32	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0088-2100-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0088-2100-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0088-2100-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0088-2100-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0088-2100-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0088-2100-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0088-2100-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0088-2100-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0088-2100-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0088-2100-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0088-2100-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0088-2100-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0088-2100-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0088-2100-24	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0088-2100-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0088-2100-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0088-2100-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0088-2100-24	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0088-2100-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0088-2100-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0088-2100-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0088-2100-24	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0088-2100-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0088-2100-24	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021024-001	PRIFTIN	RIFAPENTINE	150MG	TABLET / ORAL	AB	RLD, RS	1998-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021024-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021024-001	PRIFTIN	150MG	TABLET / ORAL	RLD, RS	1998-06-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021024-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0088-2100-03	EA - Each	0088-2100	12a2d658-aa6f-4143-8622-8c56327554ed	1	2012-07-24
0088-2100-24	EA - Each	0088-2100	165ff53e-f0a4-4503-808b-79bc5963c6c3	1	2015-10-02
0088-2100-32	EA - Each	0088-2100	12ce2da4-21ce-44e1-8cc8-d617dfc636e9	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
rifapentine	ACTIVE INGREDIENT	XJM390A33U	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
rifapentine	ACTIVE MOIETY	XJM390A33U	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
calcium stearate	INACTIVE INGREDIENT	776XM7047L	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
sodium ascorbate	INACTIVE INGREDIENT	S033EH8359	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	15

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Priftin	RIFAPENTINE	sanofi-aventis U.S. LLC	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021024 application number: NDA021024

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XJM390A33U	RIFAPENTINE	61379-65-5	RIFAPENTINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Priftin	sanofi-aventis U.S. LLC \| Sanofi S.p.A \| Sanofi S.p.A (also known as Sanofi-Aventis S.p.A)	2020-07-06	HUMAN PRESCRIPTION DRUG LABEL	20