NDC 50261-211

Bijuva

Estradiol And Progesterone

Bijuva is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Therapeuticsmd, Inc.. The primary component is Estradiol; Progesterone.

• Product ID: 50261-211_1dcd7097-ae98-4720-a569-16c35d1562ca
• NDC: 50261-211
• Product Type: Human Prescription Drug
• Proprietary Name: Bijuva
• Generic Name: Estradiol And Progesterone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-03
• Marketing Category: NDA / NDA
• Application Number: NDA210132
• Labeler Name: TherapeuticsMD, Inc.
• Substance Name: ESTRADIOL; PROGESTERONE
• Active Ingredient Strength: 1 mg/1; mg/1
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50261-211-05

1 BLISTER PACK in 1 CARTON (50261-211-05) > 5 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2019-04-03
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 50261-211-30 [50261021130]

Bijuva CAPSULE

• Marketing Category: NDA
• Application Number: NDA210132
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-03

NDC 50261-211-05 [50261021105]

Bijuva CAPSULE

• Marketing Category: NDA
• Application Number: NDA210132
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-03

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	1 mg/1

OpenFDA Data

• SPL SET ID: bc52489a-5149-411d-9665-2c75405ad15d
• Manufacturer:
  • TherapeuticsMD, Inc.
• UNII:
  • 4TI98Z838E
  • 4G7DS2Q64Y
• RxNorm Concept Unique ID - RxCUI:
  • 2108924
  • 2108930

Pharmacological Class

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

NDC Crossover Matching brand name "Bijuva" or generic name "Estradiol And Progesterone"

NDC	Brand Name	Generic Name
50261-211	Bijuva	estradiol and progesterone
69238-1690	Estradiol and Progesterone	Estradiol and Progesterone