Priftin

Product NDC: 0088-2102
11-digit product format: 000882102
Labeler code: 0088
Product ID: 0088-2102_83c11919-ca6d-49f5-8f9f-7b8405fcbaec
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: 2017-02-08
Substance: RIFAPENTINE
Active strength: 150 mg/1
Pharmacologic classes: Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Priftin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIFAPENTINE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XJM390A33U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242671	Internal RxNorm lookup
261101	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3a64fb70-b85e-43d9-8bcd-7e893f568ae1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57f117ae-fba0-aa9d-5fb3-b597089ac078	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0088-2102-01	Priftin	8 in 1 BLISTER PACK	TABLET, FILM COATED	8		14
0088-2102-24	Priftin	3 in 1 CARTON	TABLET, FILM COATED	3		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0088-2102-01	EA - Each	0088-2102	db87c4ca-020f-46da-9a94-0a94c1a4e85f	1	2019-07-02
0088-2102-24	EA - Each	0088-2102	45875709-7ba4-48ac-9e34-a83b74e8595c	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0088-2102	PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240713_3a64fb70-b85e-43d9-8bcd-7e893f568ae1.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 · 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 ndc (product): 0088-2102

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
261101	Priftin 150 MG Oral Tablet	PSN	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	14
242671	rifapentine 150 MG Oral Tablet	PSN	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	14
261101	rifapentine 150 MG Oral Tablet [Priftin]	SBD	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	14
242671	rifapentine 150 MG Oral Tablet	SCD	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	14
261101	Priftin 150 MG Oral Tablet	SY	3a64fb70-b85e-43d9-8bcd-7e893f568ae1	14
261101	Priftin 150 MG Oral Tablet	PSN	c3882444-18ca-4708-a51b-6c089664c10c	2
242671	rifapentine 150 MG Oral Tablet	PSN	c3882444-18ca-4708-a51b-6c089664c10c	2
261101	rifapentine 150 MG Oral Tablet [Priftin]	SBD	c3882444-18ca-4708-a51b-6c089664c10c	2
242671	rifapentine 150 MG Oral Tablet	SCD	c3882444-18ca-4708-a51b-6c089664c10c	2
261101	Priftin 150 MG Oral Tablet	SY	c3882444-18ca-4708-a51b-6c089664c10c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0088-2102-01	00088210201	8 in 1 BLISTER PACK						Historical
0088-2102-24	00088210224	3 BLISTER PACK in 1 CARTON (0088-2102-24) / 8 TABLET, FILM COATED in 1 BLISTER PACK (0088-2102-01)	3 blister pack	2017-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Priftin	sanofi-aventis U.S. LLC \| Sanofi S.r.l. \| EUROAPI ITALY SRL	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	14
Priftin	A-S Medication Solutions	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	9
Priftin	RPK Pharmaceuticals, Inc.	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	2