estradiol

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol .1 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8770
Product ID 0378-8770_398afa2b-e2e0-4374-aff1-d575e5bc6755
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208788
Listing Expiration 2026-12-31
Marketing Start 2017-12-29

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 03788770
Hyphenated Format 0378-8770

Supplemental Identifiers

RxCUI
310169
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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 ANDA208788 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8770-35) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

0378-8770-35 1 TUBE in 1 CARTON (0378-8770-35) / 42.5 g in 1 TUBE

Ingredients (1)

estradiol (.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": "398afa2b-e2e0-4374-aff1-d575e5bc6755", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["310169"], "spl_set_id": ["98770987-b313-4f2a-9aac-db0ab2068cc6"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8770-35)  / 42.5 g in 1 TUBE", "package_ndc": "0378-8770-35", "marketing_start_date": "20171229"}], "brand_name": "Estradiol", "product_id": "0378-8770_398afa2b-e2e0-4374-aff1-d575e5bc6755", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0378-8770", "generic_name": "Estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".1 mg/g"}], "application_number": "ANDA208788", "marketing_category": "ANDA", "marketing_start_date": "20171229", "listing_expiration_date": "20261231"}