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 CREAM
Routes
VAGINAL
Active Ingredients

estradiol hemihydrate .1 mg/g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8713
Product ID 63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209767
Listing Expiration 2026-12-31
Marketing Start 2018-03-05

Pharmacologic Class

Classes
estradiol congeners [cs] estrogen receptor agonists [moa] estrogen [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298713
Hyphenated Format 63629-8713

Supplemental Identifiers

RxCUI
310169
UNII
CXY7B3Q98Z

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 ANDA209767 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

63629-8713-1 1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

estradiol hemihydrate (.1 mg/g)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "06e2b88b-16e5-4926-bc67-7ca1c1f9156f", "openfda": {"unii": ["CXY7B3Q98Z"], "rxcui": ["310169"], "spl_set_id": ["74baff07-15df-48a8-93b8-3a317f896a56"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1)  / 42.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "63629-8713-1", "marketing_start_date": "20210819"}], "brand_name": "Estradiol", "product_id": "63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "63629-8713", "generic_name": "Estradiol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL HEMIHYDRATE", "strength": ".1 mg/g"}], "application_number": "ANDA209767", "marketing_category": "ANDA", "marketing_start_date": "20180305", "listing_expiration_date": "20261231"}