estradiol

Generic: estradiol

Labeler: alvogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler alvogen inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol hemihydrate .1 mg/g

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-104
Product ID 47781-104_0b1e69bc-c423-7849-4acc-b62466b70103
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209767
Marketing Start 2018-03-05
Marketing End 2027-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781104
Hyphenated Format 47781-104

Supplemental Identifiers

RxCUI
310169
UPC
0347781104443
UNII
CXY7B3Q98Z

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 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 (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

47781-104-44 1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 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": "0b1e69bc-c423-7849-4acc-b62466b70103", "openfda": {"upc": ["0347781104443"], "unii": ["CXY7B3Q98Z"], "rxcui": ["310169"], "spl_set_id": ["0178a92c-62b1-d5cf-cf54-2c85af88a74a"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44)  / 42.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "47781-104-44", "marketing_end_date": "20270601", "marketing_start_date": "20180625"}], "brand_name": "Estradiol", "product_id": "47781-104_0b1e69bc-c423-7849-4acc-b62466b70103", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "47781-104", "generic_name": "Estradiol", "labeler_name": "Alvogen Inc.", "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_end_date": "20270601", "marketing_start_date": "20180305"}