evamist

Generic: estradiol

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name evamist
Generic Name estradiol
Labeler padagis us llc
Dosage Form SPRAY
Routes
TRANSDERMAL
Active Ingredients

estradiol 1.53 mg/1

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-2067
Product ID 0574-2067_2da3b881-d6b1-4996-889b-cd882108af38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022014
Listing Expiration 2026-12-31
Marketing Start 2015-04-11

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 05742067
Hyphenated Format 0574-2067

Supplemental Identifiers

RxCUI
728118 728122
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 evamist (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA022014 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1.53 mg/1
source: ndc
Packaging
  • 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)
  • 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)
source: ndc

Packages (2)

0574-2067-00 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00) 0574-2067-27 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)

Ingredients (1)

estradiol (1.53 mg/1)

Linked Drug Pages (1)

Evamist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "2da3b881-d6b1-4996-889b-cd882108af38", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["728118", "728122"], "spl_set_id": ["9a0aa631-133d-406b-9d32-8a1a99af4e50"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)", "package_ndc": "0574-2067-00", "marketing_start_date": "20150411"}, {"sample": false, "description": "56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)", "package_ndc": "0574-2067-27", "marketing_start_date": "20150411"}], "brand_name": "Evamist", "product_id": "0574-2067_2da3b881-d6b1-4996-889b-cd882108af38", "dosage_form": "SPRAY", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0574-2067", "generic_name": "Estradiol", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Evamist", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1.53 mg/1"}], "application_number": "NDA022014", "marketing_category": "NDA", "marketing_start_date": "20150411", "listing_expiration_date": "20261231"}