HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

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HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE hydrocodone bitartrate and homatropine methylbromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-577
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg in 5 mL
HOMATROPINE METHYLBROMIDE (METHYLHOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SUCROSE
SORBITOL
ANHYDROUS CITRIC ACID
CHERRY
FD&C RED NO. 40
CARAMEL
WATER
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-577-10 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204765 09/19/2018
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharma Inc. 116943196 manufacture (13668-577)

Revised: 01/2019 Torrent Pharmaceuticals Limited

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