estradiol

Generic: estradiol

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler bryant ranch prepack
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

estradiol 10 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8804
Product ID 63629-8804_b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206388
Listing Expiration 2026-12-31
Marketing Start 2017-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298804
Hyphenated Format 63629-8804

Supplemental Identifiers

RxCUI
884707
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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 estradiol (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA206388 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/1
source: ndc
Packaging
  • 18 BLISTER PACK in 1 CARTON (63629-8804-1) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR
source: ndc

Packages (1)

63629-8804-1 18 BLISTER PACK in 1 CARTON (63629-8804-1) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR

Ingredients (1)

estradiol (10 ug/1)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["884707"], "spl_set_id": ["d9514497-6b9e-4c13-950b-6b036ff101c1"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "18 BLISTER PACK in 1 CARTON (63629-8804-1)  / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR", "package_ndc": "63629-8804-1", "marketing_start_date": "20210910"}], "brand_name": "Estradiol", "product_id": "63629-8804_b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020", "dosage_form": "INSERT", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "63629-8804", "generic_name": "Estradiol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "10 ug/1"}], "application_number": "ANDA206388", "marketing_category": "ANDA", "marketing_start_date": "20170724", "listing_expiration_date": "20261231"}