NDC Code(s) : 50090-0421-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Propranolol Hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0421(NDC:43478-901)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V)
(PROPRANOLOL - UNII:9Y8NXQ24VQ) 		PROPRANOLOL HYDROCHLORIDE80 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color WHITE (white), BLUE (blue) Score no score
Shape CAPSULE (CAPSULE) Size 16 mm
Flavor Imprint Code AK;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0421-0 30 in 1 BOTTLE Type 0: Not a Combination Product29/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA018553 02/25/2009 07/01/2016

PRINCIPAL DISPLAY PANEL

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