Application 040792

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	350MG	No	No
002	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	250MG	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
A040792-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2009-08-06
A040792-002	CARISOPRODOL	CARISOPRODOL	250MG	TABLET / ORAL	AB		2016-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040792-001	AA
A040792-002	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	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`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	A040792-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	eebb9409-e333-4b9f-8059-6588c35ab578	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	fd03c357-b199-c2b2-e053-6294a90abe2e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
Carisoprodol	CARISOPRODOL	Direct_Rx	ead8294f-fd27-5c3d-e053-2a95a90a64af	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792 ndc (product): 72189-386
carisoprodol	CARISOPRODOL	Asclemed USA, Inc.	301f5e6a-54e1-4885-b9cb-de475de59b22	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	b72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792 ndc (product): 71335-9613
carisoprodol	CARISOPRODOL	Aurobindo Pharma Limited	79637c7b-fe7b-436c-892b-6c36abfdcacc	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792 ndc (product): 65862-158 ndc (product): 65862-693
carisoprodol	CARISOPRODOL	Rising Pharma Holdings, Inc.	4d2470cb-7a5d-45f0-b005-534458833d91	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792 ndc (product): 16571-780 ndc (product): 16571-781

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-780	carisoprodol	carisoprodol	Rising Pharma Holdings, Inc.	ANDA	Current
16571-780	carisoprodol	carisoprodol	Rising Pharma Holdings, Inc.	ANDA	Current
16571-781	carisoprodol	carisoprodol	Rising Pharma Holdings, Inc.	ANDA	Current
16571-781	carisoprodol	carisoprodol	Rising Pharma Holdings, Inc.	ANDA	Current
64980-380	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-380	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-380	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-381	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-381	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-381	carisoprodol	carisoprodol	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-158	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-158	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-158	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-158	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-158	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-693	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-693	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-693	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-693	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
65862-693	carisoprodol	carisoprodol	Aurobindo Pharma Limited	ANDA	Current
71335-9613	carisoprodol	carisoprodol	Bryant Ranch Prepack	ANDA	Current
72189-386	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current
72189-386	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current