estradiol vaginal cream

Generic: estradiol

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol vaginal cream
Generic Name estradiol
Labeler prasco laboratories
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol .1 mg/g

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-002
Product ID 66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212313
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

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 66993002
Hyphenated Format 66993-002

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 cream (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA212313 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

66993-002-10 1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE

Ingredients (1)

estradiol (.1 mg/g)

Linked Drug Pages (1)

Estradiol Vaginal Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "b871564a-2980-4404-a9f5-f52e3f3cecd6", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["310169"], "spl_set_id": ["c895ac14-5dbd-4201-bf3e-ba7c38a4e994"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (66993-002-10)  / 42.5 g in 1 TUBE", "package_ndc": "66993-002-10", "marketing_start_date": "20211001"}], "brand_name": "Estradiol Vaginal Cream", "product_id": "66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "66993-002", "generic_name": "estradiol", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol Vaginal Cream", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".1 mg/g"}], "application_number": "ANDA212313", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}