NDC 65162-226

YUVAFEM

Estradiol

YUVAFEM is a Vaginal Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Estradiol.

• Product ID: 65162-226_031f1183-cb64-450f-8542-14bda071e6ea
• NDC: 65162-226
• Product Type: Human Prescription Drug
• Proprietary Name: YUVAFEM
• Generic Name: Estradiol
• Dosage Form: Tablet
• Route of Administration: VAGINAL
• Marketing Start Date: 2016-10-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205256
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 10 ug/1
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65162-226-21

8 APPLICATOR in 1 CARTON (65162-226-21) > 1 TABLET in 1 APPLICATOR

• Marketing Start Date: 2016-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-226-21 [65162022621]

YUVAFEM TABLET

• Marketing Category: ANDA
• Application Number: ANDA205256
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-17

NDC 65162-226-23 [65162022623]

YUVAFEM TABLET

• Marketing Category: ANDA
• Application Number: ANDA205256
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-17

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	10 ug/1

OpenFDA Data

• SPL SET ID: 30c7f6ba-7a9e-4853-b3e4-e00a46560224
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 884707
  • 1797113
• UPC Code:
  • 0365162226218

Pharmacological Class

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

Medicade Reported Pricing

65162022623 YUVAFEM 10 MCG VAGINAL INSERT

Pricing Unit: EA | Drug Type:

65162022621 YUVAFEM 10 MCG VAGINAL INSERT

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
69238-1524	Yuvafem	Yuvafem
42291-962	Yuvafem	Yuvafem
65162-226	YUVAFEM	YUVAFEM
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