(+-)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate | 11792 | TABLET;ORAL | 350MG

2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 14 USDMF, 1 CEP/COS, 6 EU WC, 9 NDC API, 7 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

43 FDF Dossiers, 42 FDA Orange Book, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 250MG, TABLET;ORAL - 350MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 35 Direct Compression, 30 Disintegrants & Superdisintegrants, 25 Controlled & Modified Release, 24 Granulation, 20 Lubricants & Glidants, 18 Co-Processed Excipients, 16 Thickeners and Stabilizers, 10 Film Formers & Plasticizers, 9 Taste Masking, 9 Solubilizers, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Rheology Modifiers, 3 Parenteral, 2 Coloring Agents, 2 Topical, 1 Surfactant & Foaming Agents

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 11792 / DOSAGE - TABLET;ORAL - 350MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARISOPRODOL(UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)	CARISOPRODOL	250mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Actavis Pharma, Inc.	Bryant Ranch Prepack	Ingenus Pharmaceuticals NJ, LLC	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	RedPharm Drug, Inc.	REMEDYREPACK INC.	Rising Pharmaceuticals, Inc.	St. Mary's Medical Park Pharmacy	A-S Medication Solutions LLC	American Health Packaging	Cardinal Health	Carlsbad Technology, Inc.	Hikma Pharmaceuticals USA Inc.	Jubilant Cadista Pharmaceuticals Inc.	Lake Erie Medical DBA Quality Care Products LLC	Medsource Pharmaceuticals	Nostrum Laboratories, Inc.	Par Pharmaceutical	Quality Care Products, LLC	Strides Pharma Inc.	Sun Pharmaceutical Industries Limited	Unit Dose Services	West-ward Pharmaceutical Corp	Aphena Pharma Solutions - Tennessee, LLC	McKesson Corporation dba SKY Packaging	Preferred Pharmaceuticals Inc.	Proficient Rx LP	Aurobindo Pharma Limited	Bionpharma Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE(68401960MK)
DOCUSATE SODIUM(F05Q2T2JA0)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHYLCELLULOSE (100 CPS)(4GFU244C4J)
METHYLCELLULOSE (4000 CPS)(MRJ667KA5E)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
Povidone K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)

Drug Product Composition: (+-)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate