Application 040188

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	350MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040188-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		1997-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040188-001	AA

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 · 42 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	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040188-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040188-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040188-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040188-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040188-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040188-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040188-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040188-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040188-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040188-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040188-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040188-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040188-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040188-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040188-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040188-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040188-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040188-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040188-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040188-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040188-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040188-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040188-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040188-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040188-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040188-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040188-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040188-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040188-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040188-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040188-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040188-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040188-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040188-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040188-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040188-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040188-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040188-001	AA	1	`a50c72e98297…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	b83f7fd1-11e3-4e94-ae53-4637e892b372	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 70518-2800
CARISOPRODOL	CARISOPRODOL	Directrx	d5cc9f99-59ae-55db-e053-2995a90affb7	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 72189-310
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	6c15f559-c045-4271-86ef-e001aad39c33	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 50090-5955
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	88f9b969-4225-49d6-9e4c-8c397ba7b50c	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 50090-5953
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	4626a7a7-c433-4dab-8deb-e6e45de493a6	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 72789-182
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	9d251c26-c893-425a-b8ac-20c06e50e80c	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 72789-190
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	f8aee817-c652-441e-b99a-8cbc4e6d06ef	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	95e13b8c-3558-43f0-b888-90978db878fb	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 71335-9621
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	acc7f959-55ac-4d9b-8ef4-4538378364e6	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 63629-2416
Carisoprodol	CARISOPRODOL	Oxford Pharmaceuticals, LLC	03c3455f-e217-4a7e-908f-609333dc35fc	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 69584-111
Carisoprodol	CARISOPRODOL	Medsource Pharmaceuticals	125023cb-45c2-1685-e063-6394a90af089	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2484de44-b36a-421c-a4d9-64c201694754	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Proficient Rx LP	b04fbd67-9ac5-4043-87e9-c3804d1e5d0c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 71205-704
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2179f18b-df15-4bf6-a7c7-6d9960f49a42	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 71610-617

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5953	Carisoprodol	Carisoprodol	A-S Medication Solutions	ANDA	Current
50090-5955	Carisoprodol	Carisoprodol	A-S Medication Solutions	ANDA	Current
55700-954	Carisoprodol	Carisoprodol	Quality Care Products, LLC	ANDA	Current
55700-954	Carisoprodol	Carisoprodol	Quality Care Products, LLC	ANDA	Current
63629-2416	Carisoprodol	Carisoprodol	Bryant Ranch Prepack	ANDA	Current
63629-2416	Carisoprodol	Carisoprodol	Bryant Ranch Prepack	ANDA	Current
69036-920	Vanadom	Carisoprodol	Sallus Laboratories, LLC	ANDA	Current
69036-920	Vanadom	Carisoprodol	Sallus Laboratories, LLC	ANDA	Current
69584-111	Carisoprodol	Carisoprodol	Oxford Pharmaceuticals, LLC	ANDA	Current
70518-2800	Carisoprodol	Carisoprodol	REMEDYREPACK INC.	ANDA	Current
70518-2800	Carisoprodol	Carisoprodol	REMEDYREPACK INC.	ANDA	Current
70518-2800	Carisoprodol	Carisoprodol	REMEDYREPACK INC.	ANDA	Current
70518-2800	Carisoprodol	Carisoprodol	REMEDYREPACK INC.	ANDA	Current
71205-704	Carisoprodol	Carisoprodol	Proficient Rx LP	ANDA	Current
71335-9621	Carisoprodol	Carisoprodol	Bryant Ranch Prepack	ANDA	Current
71610-617	Carisoprodol	Carisoprodol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-310	CARISOPRODOL	CARISOPRODOL	Directrx	ANDA	Current
72189-310	CARISOPRODOL	CARISOPRODOL	Directrx	ANDA	Current
72189-310	CARISOPRODOL	CARISOPRODOL	Directrx	ANDA	Current
72789-182	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-182	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-190	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-190	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-190	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-190	Carisoprodol	Carisoprodol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current