Labetalol Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 10135-0711-05

Labetalol Hydrochloride Tablets, USP 100 mg

Rx Only 500 Tablets

PRINCIPAL DISPLAY PANEL
NDC 10135-0711-05
Labetalol Hydrochloride Tablets, USP 100 mg
Rx Only 500 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0712-01

Labetalol Hydrochloride Tablets, USP 200 mg

Rx Only 100 Tablets

PRINCIPAL  DISPLAY PANEL
NDC 10135-0712-01
Labetalol Hydrochloride Tablets, USP 200 mg
Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0712-05

Labetalol Hydrochloride Tablets, USP 200 mg

Rx Only 500 Tablets

PRINCIPAL  DISPLAY PANEL
NDC 10135-0712-05
Labetalol Hydrochloride Tablets, USP 200 mg
Rx Only 500 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0713-01

Labetalol Hydrochloride Tablets, USP 300 mg

Rx Only 100 Tablets

PRINCIPAL  DISPLAY PANEL
NDC 10135-0713-01
Labetalol Hydrochloride Tablets, USP 300 mg
Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0713-05

Labetalol Hydrochloride Tablets, USP 300 mg

Rx Only 500 Tablets

PRINCIPAL  DISPLAY PANEL
NDC 10135-0713-05
Labetalol Hydrochloride Tablets, USP 300 mg
Rx Only 500 Tablets
(click image for full-size original)

Revised: 10/2020 Marlex Pharmaceuticals, Inc.

LABETALOL HYDROCHLORIDE
labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
STARCH, CORN
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code I;126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-711-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10135-711-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 10/01/2020
LABETALOL HYDROCHLORIDE
labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-712
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code I;127
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-712-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10135-712-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 10/01/2020
LABETALOL HYDROCHLORIDE
labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-713
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 300 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYSORBATE 80
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code I;130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-713-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10135-713-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 10/01/2020
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 10/2020 Marlex Pharmaceuticals Inc

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