Labetalol HCl (Page 5 of 5)

Package/Label Display Panel – Carton – 200 mg

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

NDC 60687-125-01

Labetalol
Hydrochloride
Tablets USP

200 mg

100 Tablets (10 x 10)

Each Tablet Contains:
Labetalol Hydrochloride USP……………….……………200 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 68001-204, BluePoint Laboratories.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

712501 0412501/0116OS

Package/Label Display Panel – Blister – 200 mg

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

Labetalol
Hydrochloride Tablet USP

200 mg

Package/Label Display Panel – Carton – 300 mg

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

NDC 60687-136-01

Labetalol
Hydrochloride
Tablets USP

300 mg

100 Tablets (10 x 10)

Each Tablet Contains:
Labetalol Hydrochloride USP……………….……………300 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 68001-206, BluePoint Laboratories.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

713601 0413601/0116OS

Package/Label Display Panel – Blister – 300 mg

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

Labetalol
Hydrochloride Tablet USP

300 mg

LABETALOL HCL labetalol hcl tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-114(NDC:68001-205)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code E;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-114-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-114-11)
1 NDC:60687-114-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-114-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075113 07/22/2015 10/31/2020
LABETALOL HCL labetalol hcl tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-125(NDC:68001-204)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code E;117
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-125-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-125-11)
1 NDC:60687-125-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-125-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075113 10/27/2015 10/31/2020
LABETALOL HCL labetalol hcl tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-136(NDC:68001-206)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code E;118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-136-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-136-11)
1 NDC:60687-136-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-136-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075113 09/30/2015 08/31/2020
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-114), repack (60687-125), repack (60687-136)

Revised: 04/2019 American Health Packaging

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