NDC 50090-2321

ESTRACE

Estradiol

ESTRACE is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Estradiol.

• Product ID: 50090-2321_13a62a0b-56f4-4061-ad79-4825243c1511
• NDC: 50090-2321
• 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: A-S Medication Solutions
• 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: 2021-12-31

Packaging

NDC 50090-2321-0

1 TUBE in 1 CARTON (50090-2321-0) > 42.5 g in 1 TUBE

• Marketing Start Date: 2016-03-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2321-0 [50090232100]

ESTRACE CREAM

• Marketing Category: ANDA
• Application Number: ANDA086069
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-02

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.1 mg/g

OpenFDA Data

• SPL SET ID: da52a602-f2a2-4382-be07-30351c58cc4b
• Manufacturer:
  • A-S Medication Solutions
• 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