NDC 0430-3754

ESTRACE

Estradiol

ESTRACE is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Estradiol.

• Product ID: 0430-3754_2e1d916c-1443-4349-9695-572e4e662983
• NDC: 0430-3754
• Product Type: Human Prescription Drug
• Proprietary Name: ESTRACE
• Generic Name: Estradiol
• Dosage Form: Cream
• Route of Administration: VAGINAL
• Marketing Start Date: 2001-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086069
• Labeler Name: Allergan, Inc.
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 0 mg/g
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0430-3754-14

36 CARTON in 1 CASE (0430-3754-14) > 1 TUBE, WITH APPLICATOR in 1 CARTON > 42.5 g in 1 TUBE, WITH APPLICATOR

• Marketing Start Date: 2001-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0430-3754-14 [00430375414]

ESTRACE CREAM

• Marketing Category: ANDA
• Application Number: ANDA086069
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2001-07-01

NDC 0430-3754-95 [00430375495]

ESTRACE CREAM

• Marketing Category: ANDA
• Application Number: ANDA086069
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-07-01
• Marketing End Date: 2017-05-11

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.1 mg/g

OpenFDA Data

• SPL SET ID: dfc41fcd-c5ba-4b25-b647-cf04d3988b3e
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 310169
  • 890918

Pharmacological Class

• Estradiol Congeners [CS]
• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]

NDC Crossover Matching brand name "ESTRACE" or generic name "Estradiol"

NDC	Brand Name	Generic Name
0430-0722	Estrace	Estrace
0430-0720	Estrace	Estrace
0430-0721	Estrace	Estrace
0430-3754	ESTRACE	ESTRACE
50090-2321	ESTRACE	ESTRACE
0023-5885	Alora	Estradiol
0023-5886	Alora	Estradiol
0023-5887	Alora	Estradiol
0023-5888	Alora	Estradiol
0037-4801	ELESTRIN	ESTRADIOL
0037-4802	ELESTRIN	ESTRADIOL
0013-2150	Estring	estradiol
0078-0343	Vivelle-Dot	estradiol
0078-0344	Vivelle-Dot	estradiol
0078-0345	Vivelle-Dot	estradiol
0078-0346	Vivelle-Dot	estradiol
0078-0365	Vivelle-Dot	estradiol