CARISOPRODOL

Product NDC: 10544-088
11-digit product format: 105440088
Labeler code: 10544
Product ID: 10544-088_116968c7-c19d-4858-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARISOPRODOL
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA040823
Marketing category: ANDA
Marketing start: 2012-10-15
Marketing end: 0000-00-00
Substance: CARISOPRODOL
Active strength: 350 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
10544-088-30	2020-01-31	C162847	48780-1	9d75b9d0-cba1-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-088-30	CARISOPRODOL	30 in 1 BOTTLE	TABLET	30		1

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-088	CARISOPRODOL TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20150316_116968c7-c19c-4858-e054-00144ff8d46c.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	116968c7-c19c-4858-e054-00144ff8d46c	1
197446	carisoprodol 350 MG Oral Tablet	SCD	116968c7-c19c-4858-e054-00144ff8d46c	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-088-30	10544008830	30 in 1 BOTTLE	Historical