carisoprodol

Product NDC: 76420-853
11-digit product format: 764200853
Labeler code: 76420
Product ID: 76420-853_21e58fc9-d824-4d1d-e063-6294a90a2acc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA040792
Marketing category: ANDA
Marketing start: 2009-08-06
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040792-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2009-08-06
A040792-002	CARISOPRODOL	CARISOPRODOL	250MG	TABLET / ORAL	AB		2016-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040792-001	AA
A040792-002	AB

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 3 · 84 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	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A040792-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197446	Internal RxNorm lookup
730794	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
301f5e6a-54e1-4885-b9cb-de475de59b22	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
76420-853-00	carisoprodol	1000 in 1 BOTTLE	TABLET	1000	1
76420-853-01	carisoprodol	100 in 1 BOTTLE	TABLET	100	1
76420-853-05	carisoprodol	500 in 1 BOTTLE	TABLET	500	1
76420-853-30	carisoprodol	30 in 1 BOTTLE	TABLET	30	1
76420-853-60	carisoprodol	60 in 1 BOTTLE	TABLET	60	1
76420-853-90	carisoprodol	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-853	CARISOPRODOL TABLET [ASCLEMED USA, INC.]	1	Current NDC, 6 package rows	20240915_301f5e6a-54e1-4885-b9cb-de475de59b22.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	eebb9409-e333-4b9f-8059-6588c35ab578	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	fd03c357-b199-c2b2-e053-6294a90abe2e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
Carisoprodol	CARISOPRODOL	Direct_Rx	ead8294f-fd27-5c3d-e053-2a95a90a64af	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Asclemed USA, Inc.	301f5e6a-54e1-4885-b9cb-de475de59b22	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792 ndc (product): 76420-853
carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	b72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Aurobindo Pharma Limited	79637c7b-fe7b-436c-892b-6c36abfdcacc	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Rising Pharma Holdings, Inc.	4d2470cb-7a5d-45f0-b005-534458833d91	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792

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
730794	carisoprodol 250 MG Oral Tablet	PSN	301f5e6a-54e1-4885-b9cb-de475de59b22	1
197446	carisoprodol 350 MG Oral Tablet	PSN	301f5e6a-54e1-4885-b9cb-de475de59b22	1
730794	carisoprodol 250 MG Oral Tablet	SCD	301f5e6a-54e1-4885-b9cb-de475de59b22	1
197446	carisoprodol 350 MG Oral Tablet	SCD	301f5e6a-54e1-4885-b9cb-de475de59b22	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-853-00	76420085300	1000 TABLET in 1 BOTTLE (76420-853-00)	1000 tablet	2024-09-12	No	No	Current
76420-853-01	76420085301	100 TABLET in 1 BOTTLE (76420-853-01)	100 tablet	2024-09-12	No	No	Current
76420-853-05	76420085305	500 TABLET in 1 BOTTLE (76420-853-05)	500 tablet	2024-09-12	No	No	Current
76420-853-30	76420085330	30 TABLET in 1 BOTTLE (76420-853-30)	30 tablet	2024-09-12	No	No	Current
76420-853-60	76420085360	60 TABLET in 1 BOTTLE (76420-853-60)	60 tablet	2024-09-12	No	No	Current
76420-853-90	76420085390	90 TABLET in 1 BOTTLE (76420-853-90)	90 tablet	2024-09-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
carisoprodol	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	1