NDC Code(s) : 69189-0819-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

propranolol hydrochloridepropranolol hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0819(NDC:51991-819)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
propranolol hydrochloride(UNII: F8A3652H1V)
(propranolol - UNII:9Y8NXQ24VQ) 		propranolol hydrochloride120 mg
Inactive Ingredients
Ingredient Name Strength
ethylcellulose (10 MPA.S)(UNII: 3DYK7UYZ62)
diethyl phthalate(UNII: UF064M00AF)
titanium dioxide(UNII: 15FIX9V2JP)
ammonia(UNII: 5138Q19F1X)
ferrosoferric oxide(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
povidone K29/32(UNII: 390RMW2PEQ)
potassium hydroxide(UNII: WZH3C48M4T)
hypromellose phthalate (24% phthalate, 55 CST)(UNII: 87Y6436BKR)
sucrose(UNII: C151H8M554)
starch, corn(UNII: O8232NY3SJ)
polyethylene glycol 400(UNII: B697894SGQ)
Product Characteristics
Color ORANGE (Opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 120;RD203
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0819-11 in 1 DOSE PACK Type 0: Not a Combination Product02/03/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078703 03/02/2015

PRINCIPAL DISPLAY PANEL

Propranolol ER 120 mg capsule