angeliq

Generic: drospirenone and estradiol

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

Drug Facts

Product Profile

Brand Name angeliq
Generic Name drospirenone and estradiol
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

drospirenone .5 mg/1, estradiol 1 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-483
Product ID 50419-483_261d4ace-5c4e-48f6-b793-354492017e89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021355
Listing Expiration 2027-12-31
Marketing Start 2005-11-28

Pharmacologic Class

Established (EPC)
progestin [epc] estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs] estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419483
Hyphenated Format 50419-483

Supplemental Identifiers

RxCUI
1483549 1483550 1483551 1483552 1483553 1483554
UNII
N295J34A25 4TI98Z838E
NUI
M0447349 N0000175602 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 angeliq (source: ndc)
Generic Name drospirenone and estradiol (source: ndc)
Application Number NDA021355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (50419-483-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-01)
  • 1 BLISTER PACK in 1 CARTON (50419-483-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-71)
source: ndc

Packages (2)

50419-483-03 3 BLISTER PACK in 1 CARTON (50419-483-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-01) 50419-483-72 1 BLISTER PACK in 1 CARTON (50419-483-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-71)

Ingredients (2)

drospirenone (.5 mg/1) estradiol (1 mg/1)

Linked Drug Pages (1)

Angeliq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "261d4ace-5c4e-48f6-b793-354492017e89", "openfda": {"nui": ["M0447349", "N0000175602", "M0447348", "N0000175825", "N0000000100"], "unii": ["N295J34A25", "4TI98Z838E"], "rxcui": ["1483549", "1483550", "1483551", "1483552", "1483553", "1483554"], "spl_set_id": ["761834c2-6b61-4583-84c2-f1ca4a97c4f2"], "pharm_class_cs": ["Progesterone Congeners [CS]", "Estradiol Congeners [CS]"], "pharm_class_epc": ["Progestin [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": "3 BLISTER PACK in 1 CARTON (50419-483-03)  / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-01)", "package_ndc": "50419-483-03", "marketing_start_date": "20120229"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50419-483-72)  / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-71)", "package_ndc": "50419-483-72", "marketing_start_date": "20120229"}], "brand_name": "Angeliq", "product_id": "50419-483_261d4ace-5c4e-48f6-b793-354492017e89", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50419-483", "generic_name": "drospirenone and estradiol", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Angeliq", "active_ingredients": [{"name": "DROSPIRENONE", "strength": ".5 mg/1"}, {"name": "ESTRADIOL", "strength": "1 mg/1"}], "application_number": "NDA021355", "marketing_category": "NDA", "marketing_start_date": "20051128", "listing_expiration_date": "20271231"}