climara

Generic: estradiol

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name climara
Generic Name estradiol
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

estradiol .0375 mg/d

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-456
Product ID 50419-456_f1c037fa-c50c-4b14-8c81-b3578af7d437
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020375
Listing Expiration 2027-12-31
Marketing Start 2003-05-27

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 50419456
Hyphenated Format 50419-456

Supplemental Identifiers

RxCUI
238003 238004 241527 242333 310170 310174 310178 310181 403922 403923 404656 404657
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 climara (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA020375 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .0375 mg/d
source: ndc
Packaging
  • 4 PATCH in 1 CARTON (50419-456-04) / 7 d in 1 PATCH (50419-456-01)
source: ndc

Packages (1)

50419-456-04 4 PATCH in 1 CARTON (50419-456-04) / 7 d in 1 PATCH (50419-456-01)

Ingredients (1)

estradiol (.0375 mg/d)

Linked Drug Pages (1)

Climara ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "f1c037fa-c50c-4b14-8c81-b3578af7d437", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["238003", "238004", "241527", "242333", "310170", "310174", "310178", "310181", "403922", "403923", "404656", "404657"], "spl_set_id": ["1e9702c4-f2d7-4ea8-b6e8-7dca31671864"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 PATCH in 1 CARTON (50419-456-04)  / 7 d in 1 PATCH (50419-456-01)", "package_ndc": "50419-456-04", "marketing_start_date": "20030527"}], "brand_name": "Climara", "product_id": "50419-456_f1c037fa-c50c-4b14-8c81-b3578af7d437", "dosage_form": "PATCH", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "50419-456", "generic_name": "Estradiol", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Climara", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".0375 mg/d"}], "application_number": "NDA020375", "marketing_category": "NDA", "marketing_start_date": "20030527", "listing_expiration_date": "20271231"}