NDC Code(s) : 54569-5710-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quinapril Quinapril Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5710(NDC:65862-619)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE(UNII: 33067B3N2M)
(QUINAPRILAT - UNII:34SSX5LDE5) 		QUINAPRILAT20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code D;16
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5710-030 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202725 04/29/2013

PRINCIPAL DISPLAY PANEL

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