CARISOPRODOL

Product NDC: 76420-646
11-digit product format: 764200646
Labeler code: 76420
Product ID: 76420-646_0b44d519-3a0a-614d-e063-6294a90ab9b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARISOPRODOL
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA203374
Marketing category: ANDA
Marketing start: 2014-01-27
Substance: CARISOPRODOL
Active strength: 350 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: CARISOPRODOL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARISOPRODOL	350 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
21925K482H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197446	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4221d7d1-d7d6-46c4-be41-8c8e99129324	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
780d53a1-1665-e26e-d112-85333c0c8a2e	Product name	5	20220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-646-01	CARISOPRODOL	100 in 1 BOTTLE	TABLET	100	1
76420-646-30	CARISOPRODOL	30 in 1 BOTTLE	TABLET	30	1
76420-646-60	CARISOPRODOL	60 in 1 BOTTLE	TABLET	60	1
76420-646-90	CARISOPRODOL	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-646-01	EA - Each	76420-646	3fd5664a-bded-4760-be5d-a32284b791fb	1	2024-01-04
76420-646-30	EA - Each	76420-646	91c0a1dc-8af0-49ef-a96e-352f3e4b52aa	1	2024-01-04
76420-646-60	EA - Each	76420-646	98434493-6189-4ced-9120-0881c79878c9	1	2024-01-04
76420-646-90	EA - Each	76420-646	ea8157e6-c17a-4bfc-be69-f08c61eb3180	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-646	CARISOPRODOL TABLET [ASCLEMED USA, INC.]	1	Current NDC, 4 package rows	20231201_4221d7d1-d7d6-46c4-be41-8c8e99129324.zip

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
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
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
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
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
Carisoprodol	CARISOPRODOL	Direct_Rx	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203374 application number: ANDA203374
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
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
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 ndc (product): 76420-646
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
21925K482H	CARISOPRODOL	78-44-4	CARISOPRODOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197446	carisoprodol 350 MG Oral Tablet	PSN	4221d7d1-d7d6-46c4-be41-8c8e99129324	1
197446	carisoprodol 350 MG Oral Tablet	SCD	4221d7d1-d7d6-46c4-be41-8c8e99129324	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-646-01	76420064601	100 TABLET in 1 BOTTLE (76420-646-01)	100 tablet	2023-11-29	No	No	Current
76420-646-30	76420064630	30 TABLET in 1 BOTTLE (76420-646-30)	30 tablet	2023-11-29	No	No	Current
76420-646-60	76420064660	60 TABLET in 1 BOTTLE (76420-646-60)	60 tablet	2023-11-29	No	No	Current
76420-646-90	76420064690	90 TABLET in 1 BOTTLE (76420-646-90)	90 tablet	2023-11-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARISOPRODOL	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL	1