NDC Code(s) : 50261-211-30, 50261-211-05, 50261-251-30, 50261-251-05
Packager : Mayne Pharma LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bijuvaestradiol and progesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50261-211
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
estradiol(UNII: 4TI98Z838E)
(estradiol - UNII:4TI98Z838E) 		estradiol1 mg
progesterone(UNII: 4G7DS2Q64Y)
(progesterone - UNII:4G7DS2Q64Y) 		progesterone100 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
LAUROYL PEG-32 GLYCERIDES(UNII: H5ZC52369M)
GELATIN TYPE B BOVINE (200 BLOOM)(UNII: A7JR5F8DLH)
GLYCERIN(UNII: PDC6A3C0OX)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALCOHOL(UNII: 3K9958V90M)
ETHYL ACETATE(UNII: 76845O8NMZ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
AMMONIA(UNII: 5138Q19F1X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color PINK (light pink), PINK (dark pink) Score no score
Shape OVAL (OVAL) Size 15 mm
Flavor Imprint Code 1C1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50261-211-301 in 1 CARTON 04/03/2019
130 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:50261-211-051 in 1 CARTON 04/03/2019
25 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210132 04/03/2019
Bijuvaestradiol and progesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50261-251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
estradiol(UNII: 4TI98Z838E)
(estradiol - UNII:4TI98Z838E) 		estradiol0.5 mg
progesterone(UNII: 4G7DS2Q64Y)
(progesterone - UNII:4G7DS2Q64Y) 		progesterone100 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
LAUROYL PEG-32 GLYCERIDES(UNII: H5ZC52369M)
GELATIN TYPE B BOVINE (200 BLOOM)(UNII: A7JR5F8DLH)
GLYCERIN(UNII: PDC6A3C0OX)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALCOHOL(UNII: 3K9958V90M)
ETHYL ACETATE(UNII: 76845O8NMZ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
AMMONIA(UNII: 5138Q19F1X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color PINK (light pink), PINK (dark pink) Score no score
Shape OVAL (OVAL) Size 15 mm
Flavor Imprint Code 5C1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50261-251-301 in 1 CARTON 31/03/2023
130 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:50261-251-051 in 1 CARTON 31/03/2023
25 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210132 03/31/2023

LABELER - Mayne Pharma LLC(087220261)

Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions LLC 051762268 ANALYSIS(50261-211), analysis(50261-251), MANUFACTURE(50261-211), manufacture(50261-251)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 0.5 mg Carton Label

NDC 50261-251-30

Rx Only

Bijuva®

(estradiol and progesterone) capsules

0.5 mg/100 mg per capsule

TherapeuticsMD ®

30 capsules

Principal Display Panel – 0.5 mg Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 1 mg Carton Label

NDC 50261-211-30

Rx Only

Bijuva®

(estradiol and progesterone) capsules

1 mg/100 mg per capsule

TherapeuticsMD ®

30 capsules

Principal Display Panel – 1 mg Carton Label