NDC Code(s) : 50111-467-01, 50111-467-03, 50111-468-01, 50111-468-03, 50111-469-01, 50111-469-03, 50111-470-01, 50111-471-01, 50111-471-02
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Propranolol HydrochloridePropranolol Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V)
(PROPRANOLOL - UNII:9Y8NXQ24VQ) 		PROPRANOLOL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50111-467-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
2NDC:50111-467-031000 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071972 09/30/1990 03/31/2019
Propranolol HydrochloridePropranolol Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-468
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V)
(PROPRANOLOL - UNII:9Y8NXQ24VQ) 		PROPRANOLOL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50111-468-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
2NDC:50111-468-031000 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071973 09/30/1990 03/31/2019
Propranolol HydrochloridePropranolol Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-469
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V)
(PROPRANOLOL - UNII:9Y8NXQ24VQ) 		PROPRANOLOL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50111-469-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
2NDC:50111-469-031000 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071974 09/30/1990 04/30/2019
Propranolol HydrochloridePropranolol Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-470
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE(UNII: F8A3652H1V)
(PROPRANOLOL - UNII:9Y8NXQ24VQ) 		PROPRANOLOL HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50111-470-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071975 09/30/1990 02/28/2019
Propranolol HydrochloridePropranolol Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-471
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50111-471-01100 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
2NDC:50111-471-02500 in 1 BOTTLE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071976 09/30/1990 04/30/2019

PRINCIPAL DISPLAY PANEL

Propranolol Hydrochloride Tablets USP 10 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Propranolol Hydrochloride Tablets USP 20 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Propranolol Hydrochloride Tablets USP 40 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Propranolol Hydrochloride Tablets USP 60 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Propranolol Hydrochloride Tablets USP 80 mg, 100s Label