CARISOPRODOL

Product NDC: 33358-064
11-digit product format: 333580064
Labeler code: 33358
Product ID: 33358-064_c1f14976-f6a4-4389-bf36-4f053df760a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARISOPRODOL
Dosage form: TABLET
Route: ORAL
Labeler: RxChange Co.
Application: ANDA040823
Marketing category: ANDA
Marketing start: 2010-07-01
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
33358-064-30	2020-01-31	C162847	48780-1	9d75b9d1-154b-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
33358-064-60	2020-01-31	C162847	48780-1	9d75b9d1-154b-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
33358-064-90	2020-01-31	C162847	48780-1	9d75b9d1-154b-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	SPL version
33358-064-30	CARISOPRODOL	30 in 1 BOTTLE	TABLET	30	2
33358-064-60	CARISOPRODOL	60 in 1 BOTTLE	TABLET	60	2
33358-064-90	CARISOPRODOL	90 in 1 BOTTLE	TABLET	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33358-064-30	EA - Each	33358-064	f4a2edf5-2390-475b-b396-ea83493c2cee	1	2014-11-05
33358-064-60	EA - Each	33358-064	d58f9521-bfd6-47d5-a3b9-6bca701aeeda	1	2014-11-05
33358-064-90	EA - Each	33358-064	7f5fb9f3-2e22-4178-9965-04b6941d51a0	1	2014-11-05

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [RXCHANGE CO.]	2
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [RXCHANGE CO.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CARISOPRODOL TABLET [RXCHANGE CO.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [RXCHANGE CO.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CARISOPRODOL TABLET [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [RXCHANGE CO.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [RXCHANGE CO.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [RXCHANGE CO.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARISOPRODOL TABLET [RXCHANGE CO.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33358-064	CARISOPRODOL TABLET [RXCHANGE CO.]	2	Legacy NDC, 3 package rows	20141104_e0c34953-bf75-48ca-89b1-2bd2e3f0693e.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	e0c34953-bf75-48ca-89b1-2bd2e3f0693e	2
197446	carisoprodol 350 MG Oral Tablet	SCD	e0c34953-bf75-48ca-89b1-2bd2e3f0693e	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33358-064-30	33358006430	30 in 1 BOTTLE	Historical
33358-064-60	33358006460	60 in 1 BOTTLE	Historical
33358-064-90	33358006490	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARISOPRODOL	RxChange Co. \| Mirror Pharmaceuticals, LLC	2014-11-03	HUMAN PRESCRIPTION DRUG LABEL	2