Carisoprodol

Product NDC: 0143-1176
11-digit product format: 001431176
Labeler code: 0143
Product ID: 0143-1176_d10e9acd-7454-4b4f-9b51-60fc91f95dcb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA040124
Marketing category: ANDA
Marketing start: 1996-01-24
Marketing end: 2022-12-31
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: 0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-1176-01	EA - Each	0143-1176	d298f9b3-cc8d-486c-8f0d-33da965b2e9d	1	2012-07-24
0143-1176-05	EA - Each	0143-1176	83f81d16-bcf1-42a5-8d3b-5fb3e558e2cf	1	2012-07-24
0143-1176-10	EA - Each	0143-1176	46b008b0-acbe-4ee4-b83b-9cb1bd7ac942	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
CARISOPRODOL	ACTIVE MOIETY	21925K482H	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRAZOLAMINE (CARISOPRODOL, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]	18
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CARISOPRODOL TABLET [KELTMAN PHARMACEUTICALS INC.]	5
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CARISOPRODOL TABLET [H.J. HARKINS COMPANY, INC.]	4
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [STAT RX USA LLC]	3
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [STAT RX USA LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [STAT RX USA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [STAT RX USA LLC]	3
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	CARISOPRODOL TABLET [STAT RX USA LLC]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARISOPRODOL TABLET [STAT RX USA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [STAT RX USA LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [STAT RX USA LLC]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [STAT RX USA LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CARISOPRODOL TABLET [STAT RX USA LLC]	3
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [STAT RX USA LLC]	1
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [STAT RX USA LLC]	1
CARISOPRODOL	ACTIVE MOIETY	21925K482H	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARISOPRODOL TABLET [STAT RX USA LLC]	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARISOPRODOL TABLET [STAT RX USA LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARISOPRODOL TABLET [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARISOPRODOL TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARISOPRODOL TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARISOPRODOL TABLET [STAT RX USA LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CARISOPRODOL TABLET [STAT RX USA LLC]	1

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	99265e39-af23-43eb-a552-305f0a218fdf	18
197446	carisoprodol 350 MG Oral Tablet	SCD	99265e39-af23-43eb-a552-305f0a218fdf	18
197446	carisoprodol 350 MG Oral Tablet	PSN	9e517e32-d5ac-438d-b613-306e6aa6c45b	5
197446	carisoprodol 350 MG Oral Tablet	SCD	9e517e32-d5ac-438d-b613-306e6aa6c45b	5
197446	carisoprodol 350 MG Oral Tablet	PSN	037618dc-8aed-4a96-93a5-69971f2a3742	4
197446	carisoprodol 350 MG Oral Tablet	SCD	037618dc-8aed-4a96-93a5-69971f2a3742	4
197446	carisoprodol 350 MG Oral Tablet	PSN	6b9532e9-69e0-4e87-9e68-c6ec113ff8b3	3
197446	carisoprodol 350 MG Oral Tablet	SCD	6b9532e9-69e0-4e87-9e68-c6ec113ff8b3	3
197446	carisoprodol 350 MG Oral Tablet	PSN	11f93bdb-0855-4609-b6e4-700f10a639af	1
197446	carisoprodol 350 MG Oral Tablet	PSN	989b3762-6917-4e3f-9010-323665645626	1
197446	carisoprodol 350 MG Oral Tablet	SCD	11f93bdb-0855-4609-b6e4-700f10a639af	1
197446	carisoprodol 350 MG Oral Tablet	SCD	989b3762-6917-4e3f-9010-323665645626	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-1176-01	00143117601	100 TABLET in 1 BOTTLE, PLASTIC (0143-1176-01)	100 tablet	1996-01-24	2022-12-31	No	No	Current
0143-1176-05	00143117605	500 TABLET in 1 BOTTLE, PLASTIC (0143-1176-05)	500 tablet	1996-01-24	2022-12-31	No	No	Current
0143-1176-10	00143117610	1000 TABLET in 1 BOTTLE, PLASTIC (0143-1176-10)	1000 tablet	1996-01-24	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carisoprodol	H.J. Harkins Company, Inc. \| West-ward Pharmaceutical Corp	2012-09-18	HUMAN PRESCRIPTION DRUG LABEL	4
Carisoprodol	Aidarex Pharmaceuticals LLC	2012-08-30	HUMAN PRESCRIPTION DRUG LABEL	1
CARISOPRODOL	STAT Rx USA LLC \| PSS World Medical Inc.	2012-01-23	HUMAN PRESCRIPTION DRUG LABEL	3
Prazolamine	Physician Therapeutics LLC \| West-ward Pharmaceutical Corp \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	18
Carisoprodol	Keltman Pharmaceuticals Inc.	2011-01-07	HUMAN PRESCRIPTION DRUG LABEL	5
CARISOPRODOL	STAT RX USA LLC	2010-06-29	HUMAN PRESCRIPTION DRUG LABEL	1

Carisoprodol

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#