CARISOPRODOL

Product NDC: 45865-984
11-digit product format: 458650984
Labeler code: 45865
Product ID: 45865-984_9af1661c-46f5-a6a6-e053-2a95a90afefe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARISOPRODOL
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA203374
Marketing category: ANDA
Marketing start: 2014-01-27
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-984-30	2025-01-30	C162847	48780-1	2cef2736-7690-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959
45865-984-60	2025-01-30	C162847	48780-1	2cef2736-7690-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-984-30	CARISOPRODOL	30 in 1 BOTTLE	TABLET	30		1
45865-984-60	CARISOPRODOL	60 in 1 BOTTLE	TABLET	60		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-984	CARISOPRODOL TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20191231_9af17486-02ed-a54b-e053-2a95a90ad8b3.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197446	carisoprodol 350 MG Oral Tablet	PSN	9af17486-02ed-a54b-e053-2a95a90ad8b3	1
197446	carisoprodol 350 MG Oral Tablet	SCD	9af17486-02ed-a54b-e053-2a95a90ad8b3	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-984-30	45865098430	30 TABLET in 1 BOTTLE (45865-984-30)	30 tablet	2019-12-11	0000-00-00	No	No	Current
45865-984-60	45865098460	60 TABLET in 1 BOTTLE (45865-984-60)	60 tablet	2019-12-11	0000-00-00	No	No	Current