NDC 42291-962

Yuvafem

Estradiol

Yuvafem is a Vaginal Tablet in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Estradiol.

• Product ID: 42291-962_67c742f2-95a6-0e8e-e053-2991aa0a7d82
• NDC: 42291-962
• Product Type: Human Prescription Drug
• Proprietary Name: Yuvafem
• Generic Name: Estradiol
• Dosage Form: Tablet
• Route of Administration: VAGINAL
• Marketing Start Date: 2016-10-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205256
• Labeler Name: AvKARE, Inc.
• 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: 2019-12-31

Packaging

NDC 42291-962-08

8 APPLICATOR in 1 CARTON (42291-962-08) > 1 TABLET in 1 APPLICATOR (42291-962-11)

• Marketing Start Date: 2016-10-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42291-962-08 [42291096208]

Yuvafem TABLET

• Marketing Category: ANDA
• Application Number: ANDA205256
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-19

NDC 42291-962-11 [42291096211]

Yuvafem TABLET

• Marketing Category: ANDA
• Application Number: ANDA205256
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-19

NDC 42291-962-18 [42291096218]

Yuvafem TABLET

• Marketing Category: ANDA
• Application Number: ANDA205256
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-19

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	10 ug/1

OpenFDA Data

• SPL SET ID: d20abc9a-8f47-e274-c9b1-b71c9489761f
• Manufacturer:
  • AvKARE, Inc.
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 884707
  • 1797113

Pharmacological Class

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

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