NDC Code(s) : 50436-3763-5
Packager : Unit Dose Services

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-3763(NDC:59762-1061)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENOXYLATE HYDROCHLORIDE(UNII: W24OD7YW48)
(DIPHENOXYLATE - UNII:73312P173G) 		DIPHENOXYLATE HYDROCHLORIDE2.5 mg
ATROPINE SULFATE(UNII: 03J5ZE7KA5)
(ATROPINE - UNII:7C0697DR9I) 		ATROPINE SULFATE0.025 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SORBITOL(UNII: 506T60A25R)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code SEARLE;61
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50436-3763-5 10 in 1 BOTTLE Type 0: Not a Combination Product27/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA012462 02/27/2013

PRINCIPAL DISPLAY PANEL

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