Montelukast (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP
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MONTELUKAST montelukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1561(NDC:31722-726)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM (MONTELUKAST) MONTELUKAST 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
CARNAUBA WAX
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (Biege) Score no score
Shape SQUARE (rounded square) Size 8mm
Flavor Imprint Code 114;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1561-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202843 09/10/2014
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-1561)

Revised: 07/2023 NuCare Pharmaceuticals,Inc.

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