Carisoprodol

Product NDC: 45865-233
11-digit product format: 458650233
Labeler code: 45865
Product ID: 45865-233_12503134-d661-11bd-e063-6394a90a4f03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA040188
Marketing category: ANDA
Marketing start: 2020-01-20
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 1.

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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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
CARISOPRODOL	CARISOPRODOL	Directrx	d5cc9f99-59ae-55db-e053-2995a90affb7	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
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
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
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
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
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
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
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
Carisoprodol	CARISOPRODOL	Medsource Pharmaceuticals	125023cb-45c2-1685-e063-6394a90af089	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (product): 45865-233
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
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

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
125023cb-45c2-1685-e063-6394a90af089	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
45865-233-30	Carisoprodol	30 in 1 BOTTLE	TABLET	30		1
45865-233-60	Carisoprodol	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-233	CARISOPRODOL TABLET [MEDSOURCE PHARMACEUTICALS]	1	Current NDC, 2 package rows	20240228_125023cb-45c2-1685-e063-6394a90af089.zip

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	125023cb-45c2-1685-e063-6394a90af089	1
197446	carisoprodol 350 MG Oral Tablet	SCD	125023cb-45c2-1685-e063-6394a90af089	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
45865-233-30	45865023330	30 TABLET in 1 BOTTLE (45865-233-30)	30 tablet	2022-12-06	No	No	Current
45865-233-60	45865023360	60 TABLET in 1 BOTTLE (45865-233-60)	60 tablet	2023-01-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carisoprodol	Medsource Pharmaceuticals \| Oxford Pharmaceuticals, LLC	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	1