Hydrocodone Bitartrate and Homatropine Methylbromide (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocodone Homatropine Label
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Hydrocodone Homatropine Label

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
hydrocodone bitartrate and homatropine methylbromide syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-455
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
WATER
SUCROSE
GLYCERIN
PROPYLENE GLYCOL
METHYLPARABEN
PROPYLPARABEN
SORBITOL
D&C RED NO. 33
CARAMEL
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color RED Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-455-16 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:60432-455-28 3785 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088008 03/03/1983
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Revised: 01/2022 Morton Grove Pharmaceuticals, Inc.

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