Hydrocodone Bitartrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 17 USDMF, 1 KDMF, 18 NDC API, 11 Listed Suppliers

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

344 FDF Dossiers, 337 FDA Orange Book, 3 Canada, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, SOLUTION;ORAL - 4MG/5ML;5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG;5MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 11 DKSH, 2 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 15 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Bioplus Life Sciences, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

98 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 48 Direct Compression, 43 Controlled & Modified Release, 41 Disintegrants & Superdisintegrants, 40 Thickeners and Stabilizers, 34 Granulation, 31 Film Formers & Plasticizers, 30 Solubilizers, 28 Taste Masking, 22 Parenteral, 21 Topical, 21 Lubricants & Glidants, 20 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 97 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Annual Reports

MARKET PLACE

3 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

254 US Patents

254 US Patents

REF. STANDARDS & IMPURITIES

3 USP, 7 Others

Xls

Filters

Xls

USFDA APPLICATION NUMBER - 22279 / DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN(UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200mg in 5
HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)	HYDROCODONE BITARTRATE	2.5mg in 5
PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30mg in 5

Inactive Ingredients

Ingredient Name	Mission Pharmacal Company
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C RED NO. 33(9DBA0SBB0L)
FD&C BLUE NO. 1(H3R47K3TBD)
GLYCERIN(PDC6A3C0OX)
METHYLPARABEN(A2I8C7HI9T)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM CITRATE(1Q73Q2JULR)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)

Drug Product Composition: Hydrocodone Bitartrate