release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24090-450
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE 80 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)
DIETHYL PHTHALATE (UNII: UF064M00AF)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PRODUCT CHARACTERISTICS
Color GRAY (gray) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code 80;InnoPran;XL
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24090-450-77 7 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2013 08/31/2019
2 NDC:24090-450-85 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2013 08/31/2019
3 NDC:24090-450-88 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2013 08/31/2019
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021438 06/01/2013 08/31/2019
INNOPRAN XL
propranolol hydrochloride capsule, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24090-451
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE 120 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)
DIETHYL PHTHALATE (UNII: UF064M00AF)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color GRAY (gray) , WHITE (off-white) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code 120;InnoPran;XL
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24090-451-77 7 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2013 08/31/2019
2 NDC:24090-451-85 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2013&n |
