estradiol vaginal

Generic: estradiol

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol vaginal
Generic Name estradiol
Labeler avkare
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol .1 mg/g

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-426
Product ID 42291-426_485cfe5e-2e15-d6a9-e063-6394a90aa303
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210194
Listing Expiration 2027-12-31
Marketing Start 2021-02-16

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 42291426
Hyphenated Format 42291-426

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 vaginal (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA210194 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (42291-426-42) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

42291-426-42 1 TUBE in 1 CARTON (42291-426-42) / 42.5 g in 1 TUBE

Ingredients (1)

estradiol (.1 mg/g)

Linked Drug Pages (1)

Estradiol Vaginal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "485cfe5e-2e15-d6a9-e063-6394a90aa303", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["310169"], "spl_set_id": ["bb7b442d-b8c3-b7f0-e053-2a95a90a2c94"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (42291-426-42)  / 42.5 g in 1 TUBE", "package_ndc": "42291-426-42", "marketing_start_date": "20210216"}], "brand_name": "Estradiol Vaginal", "product_id": "42291-426_485cfe5e-2e15-d6a9-e063-6394a90aa303", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "42291-426", "generic_name": "Estradiol", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol Vaginal", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".1 mg/g"}], "application_number": "ANDA210194", "marketing_category": "ANDA", "marketing_start_date": "20210216", "listing_expiration_date": "20271231"}