climara pro

Generic: estradiol and levonorgestrel

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

Drug Facts

Product Profile

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

estradiol .045 mg/d, levonorgestrel .015 mg/d

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-491
Product ID 50419-491_0b51c5a2-a656-493f-a887-aeb5146b3752
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021258
Listing Expiration 2027-12-31
Marketing Start 2003-11-21

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc] progestin-containing intrauterine system [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs] progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419491
Hyphenated Format 50419-491

Supplemental Identifiers

RxCUI
402250 402252
UNII
4TI98Z838E 5W7SIA7YZW
NUI
M0447348 N0000175825 N0000000100 N0000175830 M0447349 N0000175602 N0000175832

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 pro (source: ndc)
Generic Name estradiol and levonorgestrel (source: ndc)
Application Number NDA021258 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .045 mg/d
  • .015 mg/d
source: ndc
Packaging
  • 4 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH
  • 1 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH
source: ndc

Packages (2)

50419-491-04 4 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH 50419-491-73 1 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH

Ingredients (2)

estradiol (.045 mg/d) levonorgestrel (.015 mg/d)

Linked Drug Pages (1)

Climara Pro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "0b51c5a2-a656-493f-a887-aeb5146b3752", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100", "N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["4TI98Z838E", "5W7SIA7YZW"], "rxcui": ["402250", "402252"], "spl_set_id": ["184d3092-7fc6-4375-816b-1ab06bb99cfd"], "pharm_class_cs": ["Estradiol Congeners [CS]", "Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]", "Progestin-containing Intrauterine System [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 (50419-491-04)  / 7 d in 1 PATCH", "package_ndc": "50419-491-04", "marketing_start_date": "20131121"}, {"sample": false, "description": "1 PATCH in 1 CARTON (50419-491-73)  / 7 d in 1 PATCH", "package_ndc": "50419-491-73", "marketing_start_date": "20170412"}], "brand_name": "Climara Pro", "product_id": "50419-491_0b51c5a2-a656-493f-a887-aeb5146b3752", "dosage_form": "PATCH", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "50419-491", "generic_name": "Estradiol and Levonorgestrel", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Climara Pro", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".045 mg/d"}, {"name": "LEVONORGESTREL", "strength": ".015 mg/d"}], "application_number": "NDA021258", "marketing_category": "NDA", "marketing_start_date": "20031121", "listing_expiration_date": "20271231"}