Bijuva

Product NDC: 50261-251
11-digit product format: 502610251
Labeler code: 50261
Product ID: 50261-251_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol and progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma LLC
Application: NDA210132
Marketing category: NDA
Marketing start: 2023-03-31
Substance: ESTRADIOL; PROGESTERONE
Active strength: .5; 100 mg/1; mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 50261-251_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Bijuva
Generic name: estradiol and progesterone
Dosage form: CAPSULE
Route: ORAL
Marketing start: 2023-03-31
Marketing category: NDA
Application number: NDA210132
Pharmacologic classes: Estradiol Congeners [CS]; Estrogen Receptor Agonists [MoA]; Estrogen [EPC]; Progesterone [CS]; Progesterone [EPC]
Listing expiration: 2027-12-31

Ingredient	Strength
ESTRADIOL	.5 mg/1
PROGESTERONE	100 mg/1

UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL
4G7DS2Q64Y	PROGESTERONE	57-83-0	PROGESTERONE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50261-251-05	50261025105	1 BLISTER PACK in 1 CARTON (50261-251-05) / 5 CAPSULE in 1 BLISTER PACK	1 blister pack	2023-03-31	Yes	No	Current
50261-251-30	50261025130	1 BLISTER PACK in 1 CARTON (50261-251-30) / 30 CAPSULE in 1 BLISTER PACK	1 blister pack	2023-03-31	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Bijuva	Mayne Pharma LLC \| Catalent Pharma Solutions LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	13