bijuva

Generic: estradiol and progesterone

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bijuva
Generic Name estradiol and progesterone
Labeler mayne pharma
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

estradiol .5 mg/1, progesterone 100 mg/1

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-751
Product ID 68308-751_86ad6f8e-d7b0-46b2-87da-71d9061a24e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210132
Listing Expiration 2027-12-31
Marketing Start 2023-12-01

Pharmacologic Class

Established (EPC)
estrogen [epc] progesterone [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs] progesterone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308751
Hyphenated Format 68308-751

Supplemental Identifiers

RxCUI
2108924 2108930 2632844 2632846
UNII
4TI98Z838E 4G7DS2Q64Y
NUI
M0447348 N0000175825 N0000000100 M0017672 N0000175601

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bijuva (source: ndc)
Generic Name estradiol and progesterone (source: ndc)
Application Number NDA210132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68308-751-00) / 5 CAPSULE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (68308-751-30) / 30 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

68308-751-00 1 BLISTER PACK in 1 CARTON (68308-751-00) / 5 CAPSULE in 1 BLISTER PACK 68308-751-30 1 BLISTER PACK in 1 CARTON (68308-751-30) / 30 CAPSULE in 1 BLISTER PACK

Ingredients (2)

estradiol (.5 mg/1) progesterone (100 mg/1)

Linked Drug Pages (1)

Bijuva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86ad6f8e-d7b0-46b2-87da-71d9061a24e9", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100", "M0017672", "N0000175601"], "unii": ["4TI98Z838E", "4G7DS2Q64Y"], "rxcui": ["2108924", "2108930", "2632844", "2632846"], "spl_set_id": ["59eadb88-c9f3-4871-b176-7ddd98faf9bc"], "pharm_class_cs": ["Estradiol Congeners [CS]", "Progesterone [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progesterone [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68308-751-00)  / 5 CAPSULE in 1 BLISTER PACK", "package_ndc": "68308-751-00", "marketing_start_date": "20231201"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68308-751-30)  / 30 CAPSULE in 1 BLISTER PACK", "package_ndc": "68308-751-30", "marketing_start_date": "20231201"}], "brand_name": "Bijuva", "product_id": "68308-751_86ad6f8e-d7b0-46b2-87da-71d9061a24e9", "dosage_form": "CAPSULE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "68308-751", "generic_name": "estradiol and progesterone", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bijuva", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}, {"name": "PROGESTERONE", "strength": "100 mg/1"}], "application_number": "NDA210132", "marketing_category": "NDA", "marketing_start_date": "20231201", "listing_expiration_date": "20271231"}