Application 203374

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

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
A203374-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2014-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203374-001	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	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203374-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-01-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A203374-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203374-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203374-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203374-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203374-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203374-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203374-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203374-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203374-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203374-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203374-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203374-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203374-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203374-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203374-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203374-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203374-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203374-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203374-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203374-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203374-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203374-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203374-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203374-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203374-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203374-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203374-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203374-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203374-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203374-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203374-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203374-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203374-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203374-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203374-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203374-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203374-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203374-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203374-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203374-001	AA	1	`e64feba35796…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARISOPRODOL	CARISOPRODOL	Northwind Health Company, LLC	26e466be-8066-e562-e063-6394a90a9f81	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	St. Mary's Medical Park Pharmacy	94f74800-1f0d-7814-e053-2a95a90a4f63	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 60760-397
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	269644bf-d32c-48a3-b3eb-1221150ebd22	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 63629-8478
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	a3f1343f-1337-4b99-b1ae-4189324ec2e9	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 63629-8477
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	93f909ea-2d2e-4a10-be50-7f33f3e904d4	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 63629-8479
CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	069ea892-21a6-4703-8dd3-bf19c4406479	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 50228-109
Carisoprodol	CARISOPRODOL	Direct_Rx	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 61919-878
Carisoprodol	CARISOPRODOL	Advanced Rx Pharmacy of Tennessee, LLC	f835e66e-f3f3-c3cf-e053-6294a90addf2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	fdd6318f-399f-499c-acdc-5318aa080f36	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 71335-1203
CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	93cbe188-5443-b392-e053-2995a90a9ac7	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 68071-5075
CARISOPRODOL	CARISOPRODOL	Asclemed USA, Inc.	4221d7d1-d7d6-46c4-be41-8c8e99129324	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	2178e805-8189-459f-a447-21bf1547744a	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 71205-339
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	efd7a0b4-5ec5-4929-a4cb-7d207171eed6	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 71205-241
CARISOPRODOL	CARISOPRODOL	Vensun Pharmaceuticals, Inc.	7c6015ad-2158-400d-8c22-585ab277ea49	2018-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374 ndc (product): 42543-700

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-700	CARISOPRODOL	CARISOPRODOL	Vensun Pharmaceuticals, Inc.	ANDA	Current
43353-102	CARISOPRODOL	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-102	CARISOPRODOL	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-984	CARISOPRODOL	CARISOPRODOL	medsource pharmaceuticals	ANDA	Current
50228-109	CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-109	CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-109	CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50436-1090	CARISOPRODOL	CARISOPRODOL	Unit Dose Services	ANDA	Current
55700-623	CARISOPRODOL	CARISOPRODOL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-770	CARISOPRODOL	CARISOPRODOL	Quality Care Products, LLC	ANDA	Current
60429-508	CARISOPRODOL	CARISOPRODOL	Golden State Medical Supply, Inc.	ANDA	Current
60429-508	CARISOPRODOL	CARISOPRODOL	Golden State Medical Supply, Inc.	ANDA	Current
60429-508	CARISOPRODOL	CARISOPRODOL	Golden State Medical Supply	ANDA	Current
60760-397	CARISOPRODOL	CARISOPRODOL	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-878	CARISOPRODOL	CARISOPRODOL	Direct_Rx	ANDA	Current
61919-878	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current
61919-878	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current
61919-878	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current
61919-878	Carisoprodol	Carisoprodol	Direct_Rx	ANDA	Current
63629-8202	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8202	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8477	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8477	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8478	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8478	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8479	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
63629-8479	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
67296-1404	CARISOPRODOL	CARISOPRODOL	RedPharm Drug, Inc.	ANDA	Current
67296-1404	CARISOPRODOL	CARISOPRODOL	RedPharm Drug, Inc.	ANDA	Current
67296-1404	CARISOPRODOL	CARISOPRODOL	RedPharm Drug, Inc.	ANDA	Current
68071-4610	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4610	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4610	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5075	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5075	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-663	CARISOPRODOL	CARISOPRODOL	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-241	CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	ANDA	Current
71205-241	CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	ANDA	Current
71205-339	CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	ANDA	Current
71205-339	CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	ANDA	Current
71205-339	CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	ANDA	Current
71335-0693	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
71335-0693	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
71335-1203	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
71335-1203	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
71610-097	CARISOPRODOL	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-097	CARISOPRODOL	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current