Application 040124

Type: ANDA
Sponsor: HIKMA INTL 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
A040124-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL			1996-01-24

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	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1996-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1996-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1996-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1996-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040124-001	CARISOPRODOL	350MG	TABLET / ORAL		1996-01-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040124-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040124-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040124-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040124-001	AA	1	`ea99ee380514…`

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 3 · 48 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	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Northwind Health Company, LLC	26e466be-8066-e562-e063-6394a90a9f81	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	St. Mary's Medical Park Pharmacy	94f74800-1f0d-7814-e053-2a95a90a4f63	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	269644bf-d32c-48a3-b3eb-1221150ebd22	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	eebb9409-e333-4b9f-8059-6588c35ab578	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	a3f1343f-1337-4b99-b1ae-4189324ec2e9	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	93f909ea-2d2e-4a10-be50-7f33f3e904d4	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Westminster Pharmaceuticals, LLC	bfb31551-8c57-4360-be3a-f6fbe84a891e	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Directrx	d5cc9f99-59ae-55db-e053-2995a90affb7	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	069ea892-21a6-4703-8dd3-bf19c4406479	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	6c15f559-c045-4271-86ef-e001aad39c33	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	88f9b969-4225-49d6-9e4c-8c397ba7b50c	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Direct_Rx	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Chartwell RX, LLC	a44a3dfc-a427-4584-a086-4bc0c538b125	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	Bryant Ranch Prepack	35a8e0a4-93a3-44e3-903f-4661ee1cffe8	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	Bryant Ranch Prepack	409b04af-b9fd-4ba5-afa0-3e43466f8d2d	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	1f08f4af-37c2-49b5-a4e3-284414f866fa	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Soma	CARISOPRODOL	Viatris Specialty LLC	6297cf20-830a-11dc-94c8-0002a5d5c51b	2025-08-29	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	8c0c418c-90e2-4b81-a9c0-b131c38ec874	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1176	Carisoprodol	Carisoprodol	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1176	Carisoprodol	Carisoprodol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1176	Carisoprodol	Carisoprodol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1176	Carisoprodol	Carisoprodol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9749	Carisoprodol	Carisoprodol	West-ward Pharmaceutical Corp	ANDA	Current
10544-132	Carisoprodol	Carisoprodol	Blenheim Pharmacal, Inc.	ANDA	Current
33261-387	Carisoprodol	Carisoprodol	Aidarex Pharmaceuticals LLC	ANDA	Current
52959-026	Carisoprodol	Carisoprodol	H.J. Harkins Company, Inc.	ANDA	Current
68387-600	Carisoprodol	Carisoprodol	Keltman Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29892	SUPPL	2008-01-09