Balziva (Page 7 of 7)

Package/Label Display Panel, Part 1 of 2

NDC 0555-9034-58

6 Blister Card Dispensers, 28 Tablets Each

Balziva®
(norethidrone and
ethinyl estradiol tablets USP)
0.4 mg/0.035 mg

Usual Dosage: One tablet daily for 28 consecutive days per menstrual
cycle in the following order: 21 light peach tablets followed by 7 white
tablets as prescribed.

See enclosed package insert for full prescribing information.

Pharmacist: Each foil pouch contains one combination “Detailed
Patient Labeling / Brief Summary Insert,” which is to be provided to
the patient with each prescription.

Rx only

SHAPING
WOMEN’S HEALTH®

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Package/Label Display Panel, Part 2 of 2

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BALZIVA
norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-9034
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-9034-58 6 POUCH in 1 CARTON contains a POUCH (0555-9034-79)
1 NDC:0555-9034-79 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0555-9034-58) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (0555-9034-79) and a CARTON (0555-9034-58)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
NORETHINDRONE AND ETHINYL ESTRADIOL
norethindrone and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.4 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color orange (light peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;735
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 10/16/2006
Part 2 of 2
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;944
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 10/16/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 10/16/2006
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2021 Teva Pharmaceuticals USA, Inc.

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