Application 064150

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIFAMPIN	RIFAMPIN	CAPSULE;ORAL	300MG	No	No
002	RIFAMPIN	RIFAMPIN	CAPSULE;ORAL	150MG	No	No

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…`

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 ndc (product): 42806-801 ndc (product): 42806-799

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0799	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0185-0801	Rifampin	Rifampin	Eon Labs, Inc.	ANDA	Current
0904-5282	RIFAMPIN	RIFAMPIN	Major Pharmaceuticals	ANDA	Current
0904-5282	RIFAMPIN	RIFAMPIN	Major Pharmaceuticals	ANDA	Current
0904-5282	RIFAMPIN	RIFAMPIN	Major Pharmaceuticals	ANDA	Current
0904-5282	RIFAMPIN	RIFAMPIN	Major Pharmaceuticals	ANDA	Current
21695-527	Rifampin	Rifampin	Rebel Distributors Corp	ANDA	Current
42806-799	RIFAMPIN	rifampin	EPIC PHARMA, LLC	ANDA	Current
42806-799	RIFAMPIN	rifampin	EPIC PHARMA, LLC	ANDA	Current
42806-801	RIFAMPIN	rifampin	EPIC PHARMA, LLC	ANDA	Current
42806-801	RIFAMPIN	rifampin	EPIC PHARMA, LLC	ANDA	Current
50090-4961	Rifampin	Rifampin	A-S Medication Solutions	ANDA	Current
50090-4961	Rifampin	Rifampin	A-S Medication Solutions	ANDA	Current
51079-890	Rifampin	Rifampin	Mylan Institutional Inc.	ANDA	Current
53002-6430	Rifampin	Rifampin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-6430	Rifampin	Rifampin	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-5351	Rifampin	Rifampin	Cardinal Health	ANDA	Current
63629-4042	Rifampin	Rifampin	Bryant Ranch Prepack	ANDA	Current
63629-4042	Rifampin	Rifampin	Bryant Ranch Prepack	ANDA	Current
63629-4042	Rifampin	Rifampin	Bryant Ranch Prepack	ANDA	Current
63629-4042	Rifampin	Rifampin	Bryant Ranch Prepack	ANDA	Current
63739-415	Rifampin	Rifampin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-415	Rifampin	Rifampin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-415	Rifampin	Rifampin	McKesson Corporation dba SKY Packaging	ANDA	Current
76420-060	Rifampin	Rifampin	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42785	ORIG	2011-03-10
8352	ORIG	2011-03-10