Bijuva
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
59eadb88-c9f3-4871-b176-7ddd98faf9bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
estradiol and progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-750
Application NumberNDA210132
Product Classification
M
Marketing Category
C73594
G
Generic Name
estradiol and progesterone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (17)
progesteroneActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62
Classification: IACT
estradiolActive
Quantity: 1 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
Lauroyl Peg-32 GlyceridesInactive
Code: H5ZC52369M
Classification: IACT
Gelatin Type B Bovine (200 Bloom)Inactive
Code: A7JR5F8DLH
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Ethyl AcetateInactive
Code: 76845O8NMZ
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
estradiol and progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-751
Application NumberNDA210132
Product Classification
M
Marketing Category
C73594
G
Generic Name
estradiol and progesterone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (17)
progesteroneActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
Lauroyl Peg-32 GlyceridesInactive
Code: H5ZC52369M
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Ethyl AcetateInactive
Code: 76845O8NMZ
Classification: IACT
estradiolActive
Quantity: 0.5 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
Gelatin Type B Bovine (200 Bloom)Inactive
Code: A7JR5F8DLH
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62
Classification: IACT