Estradiol (Page 5 of 5)

Package/Label Display Panel

NDC 60429-833-01

Estradiol

Tablets USP

0.5 mg

PHARMACIST: Dispense the accompanying

Patient Information Sheet to each patient.

Rx only

100 Tablets

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Package/Label Display Panel

NDC 60429-834-05

Estradiol

Tablets USP

1 mg

PHARMACIST: Dispense the accompanying

Patient Information Sheet to each patient.

Rx only

100 Tablets

//medlibrary.org/lib/images-rx/estradiol-37/60429-834-05lb-300x231.jpg
(click image for full-size original)

Package/Label Display Panel

NDC 60429-835-05

Estradiol

Tablets USP

2 mg

PHARMACIST: Dispense the accompanying

Patient Information Sheet to each patient.

Contains FD&C Yellow No. 5 (tartrazine) as

a color additive.

Rx only

100 Tablets

60429-835-05LB.jpg
(click image for full-size original)
ESTRADIOL
estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-833(NDC:51862-332)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 899;1;2;b
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-833-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040197 10/22/1997 12/31/2022
ESTRADIOL
estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-834(NDC:51862-333)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 1
D&C RED NO. 27
Product Characteristics
Color purple (light purple) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 886;1;b
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-834-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-834-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040197 10/22/1997
ESTRADIOL
estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-835(NDC:51862-334)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
ALUMINUM OXIDE
Product Characteristics
Color green Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 887;2;b
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-835-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-835-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040197 10/22/1997 10/31/2022
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-833), repack (60429-833), relabel (60429-834), repack (60429-834), relabel (60429-835), repack (60429-835)

Revised: 12/2022 Golden State Medical Supply, Inc.

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