Carisoprodol

Product NDC: 69584-111
11-digit product format: 695840111
Labeler code: 69584
Product ID: 69584-111_c2798091-3c51-4962-b72d-f11592ec00f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Oxford Pharmaceuticals, LLC
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA		1997-03-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040188-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 69584-111
Carisoprodol	CARISOPRODOL	Medsource Pharmaceuticals	125023cb-45c2-1685-e063-6394a90af089	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
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
03c3455f-e217-4a7e-908f-609333dc35fc	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	SPL version
69584-111-10	Carisoprodol	100 in 1 BOTTLE	TABLET	100	2
69584-111-50	Carisoprodol	500 in 1 BOTTLE	TABLET	500	2
69584-111-90	Carisoprodol	1000 in 1 BOTTLE	TABLET	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69584-111-10	EA - Each	69584-111	1d0dcd41-fb7e-4abc-9690-f969712356cf	1	2020-03-10
69584-111-50	EA - Each	69584-111	dfd23372-5d36-466f-8478-c08043eaa258	1	2020-07-13
69584-111-90	EA - Each	69584-111	d17e4746-5908-492b-87f5-80b3fbc878e6	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69584-111	CARISOPRODOL TABLET [OXFORD PHARMACEUTICALS, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20241228_03c3455f-e217-4a7e-908f-609333dc35fc.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	acc7f959-55ac-4d9b-8ef4-4538378364e6	103
197446	carisoprodol 350 MG Oral Tablet	SCD	acc7f959-55ac-4d9b-8ef4-4538378364e6	103
197446	carisoprodol 350 MG Oral Tablet	PSN	95e13b8c-3558-43f0-b888-90978db878fb	102
197446	carisoprodol 350 MG Oral Tablet	SCD	95e13b8c-3558-43f0-b888-90978db878fb	102
197446	carisoprodol 350 MG Oral Tablet	PSN	f8aee817-c652-441e-b99a-8cbc4e6d06ef	101
197446	carisoprodol 350 MG Oral Tablet	SCD	f8aee817-c652-441e-b99a-8cbc4e6d06ef	101
197446	carisoprodol 350 MG Oral Tablet	PSN	b83f7fd1-11e3-4e94-ae53-4637e892b372	14
197446	carisoprodol 350 MG Oral Tablet	SCD	b83f7fd1-11e3-4e94-ae53-4637e892b372	14
197446	carisoprodol 350 MG Oral Tablet	PSN	4626a7a7-c433-4dab-8deb-e6e45de493a6	9
197446	carisoprodol 350 MG Oral Tablet	SCD	4626a7a7-c433-4dab-8deb-e6e45de493a6	9
197446	carisoprodol 350 MG Oral Tablet	PSN	9d251c26-c893-425a-b8ac-20c06e50e80c	8
197446	carisoprodol 350 MG Oral Tablet	SCD	9d251c26-c893-425a-b8ac-20c06e50e80c	8
197446	carisoprodol 350 MG Oral Tablet	PSN	d5cc9f99-59ae-55db-e053-2995a90affb7	6
197446	carisoprodol 350 MG Oral Tablet	SCD	d5cc9f99-59ae-55db-e053-2995a90affb7	6
197446	carisoprodol 350 MG Oral Tablet	PSN	88f9b969-4225-49d6-9e4c-8c397ba7b50c	5
197446	carisoprodol 350 MG Oral Tablet	PSN	6c15f559-c045-4271-86ef-e001aad39c33	5
197446	carisoprodol 350 MG Oral Tablet	SCD	88f9b969-4225-49d6-9e4c-8c397ba7b50c	5
197446	carisoprodol 350 MG Oral Tablet	SCD	6c15f559-c045-4271-86ef-e001aad39c33	5
197446	carisoprodol 350 MG Oral Tablet	PSN	2484de44-b36a-421c-a4d9-64c201694754	2
197446	carisoprodol 350 MG Oral Tablet	PSN	03c3455f-e217-4a7e-908f-609333dc35fc	2
197446	carisoprodol 350 MG Oral Tablet	SCD	2484de44-b36a-421c-a4d9-64c201694754	2
197446	carisoprodol 350 MG Oral Tablet	SCD	03c3455f-e217-4a7e-908f-609333dc35fc	2
197446	carisoprodol 350 MG Oral Tablet	PSN	125023cb-45c2-1685-e063-6394a90af089	1
197446	carisoprodol 350 MG Oral Tablet	PSN	b04fbd67-9ac5-4043-87e9-c3804d1e5d0c	1
197446	carisoprodol 350 MG Oral Tablet	SCD	125023cb-45c2-1685-e063-6394a90af089	1
197446	carisoprodol 350 MG Oral Tablet	SCD	b04fbd67-9ac5-4043-87e9-c3804d1e5d0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69584-111-10	69584011110	100 TABLET in 1 BOTTLE (69584-111-10)	100 tablet	2020-01-20	0000-00-00	No	No	Current
69584-111-50	69584011150	500 TABLET in 1 BOTTLE (69584-111-50)	500 tablet	2020-01-20	0000-00-00	No	No	Current
69584-111-90	69584011190	1000 TABLET in 1 BOTTLE (69584-111-90)	1000 tablet	2020-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carisoprodol	REMEDYREPACK INC.	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	15
CARISOPRODOL	Directrx	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	6
Carisoprodol	A-S Medication Solutions	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	5
Carisoprodol	A-S Medication Solutions	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	5
Carisoprodol	PD-Rx Pharmaceuticals, Inc.	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	9
Carisoprodol	PD-Rx Pharmaceuticals, Inc.	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	8
Carisoprodol	Bryant Ranch Prepack	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	101
Carisoprodol	Bryant Ranch Prepack	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	102
Carisoprodol	Bryant Ranch Prepack	2025-01-24	HUMAN PRESCRIPTION DRUG LABEL	103
Carisoprodol	Oxford Pharmaceuticals, LLC	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	2
Carisoprodol	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	4
Carisoprodol	Medsource Pharmaceuticals \| Oxford Pharmaceuticals, LLC	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	1
Carisoprodol	Aphena Pharma Solutions - Tennessee, LLC	2023-12-11	HUMAN PRESCRIPTION DRUG LABEL	2
Carisoprodol	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	1