Labetalol Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Labetalol Hydrochloride Tablets, USP, for oral administration, are available as

100 mg: Round, beige, film-coated tablets, plain on one side, scored and debossed with “I/126” on the other side and supplied as:

NDC 71247-126-01 bottles of 100

NDC 71247-126-05 bottles of 500

200 mg: Round, white, film-coated tablets, plain on one side, scored and debossed with “I/127” on the other side and supplied as:

NDC 71247-127-01 bottles of 100

NDC 71247-127-05 bottles of 500

300 mg: Round, blue, film-coated tablets, plain on one side and debossed with “I/130” on the other side and supplied as:

NDC 71247-130-01 bottles of 100

NDC 71247-130-05 bottles of 500

Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required.

To report SUSPECTED ADVERSE REACTIONS, contact Innogenix, LLC. at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Distributed by:

Innogenix, LLC.

Amityville, NY 11701

Rev. 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-126 -01

Labetalol Hydrochloride Tablets USP, 100 mg

100 Tablets

Rx Only

Innogenix, LLC.

Labetalol 100 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-127 -01

Labetalol Hydrochloride Tablets USP, 200 mg

100 Tablets

Rx Only
Innogenix, LLC.

Labetalol 200 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-130 -01

Labetalol Hydrochloride Tablets USP, 300 mg

100 Tablets

Rx Only
Innogenix, LLC.

Labetalol 300 mg
(click image for full-size original)

LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-126
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
POLYSORBATE 80
STARCH, CORN
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
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:71247-126-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71247-126-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 02/08/2021
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-127
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
STARCH, CORN
TITANIUM DIOXIDE
POLYDEXTROSE
TRIACETIN
POLYETHYLENE GLYCOL, UNSPECIFIED
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:71247-127-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71247-127-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 02/08/2021
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71247-130
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
STARCH, CORN
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C BLUE NO. 2
POLYSORBATE 80
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code I;130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71247-130-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71247-130-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 02/08/2021
Labeler — Innogenix, Inc. (080501434)

Revised: 02/2021 Innogenix, Inc.

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