NDC 0037-4801

ELESTRIN

Estradiol

ELESTRIN is a Topical Gel, Metered in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Estradiol.

• Product ID: 0037-4801_02a70900-90dd-43e0-b5f6-e618ccb07859
• NDC: 0037-4801
• Product Type: Human Prescription Drug
• Proprietary Name: ELESTRIN
• Generic Name: Estradiol
• Dosage Form: Gel, Metered
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-06-02
• Marketing Category: NDA / NDA
• Application Number: NDA021813
• Labeler Name: Meda Pharmaceuticals
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 1 mg/.87g
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0037-4801-70

2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) > 35 g in 1 BOTTLE, PUMP (0037-4801-35)

• Marketing Start Date: 2018-11-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-4801-70 [00037480170]

ELESTRIN GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-11-05

NDC 0037-4801-35 [00037480135]

ELESTRIN GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021813
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-06-02

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.52 mg/.87g

OpenFDA Data

• SPL SET ID: eff2dea1-f117-11e3-ac10-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 706467
  • 226597

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0037-4801	ELESTRIN	ESTRADIOL
0037-4802	ELESTRIN	ESTRADIOL
0023-5885	Alora	Estradiol
0023-5886	Alora	Estradiol
0023-5887	Alora	Estradiol
0023-5888	Alora	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