NDC 50419-482

Angeliq

Drospirenone And Estradiol

Angeliq is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Drospirenone; Estradiol.

Product ID50419-482_5a4eb954-8197-4c51-aaf7-81b1956c3c23
NDC50419-482
Product TypeHuman Prescription Drug
Proprietary NameAngeliq
Generic NameDrospirenone And Estradiol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-29
Marketing CategoryNDA / NDA
Application NumberNDA021355
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameDROSPIRENONE; ESTRADIOL
Active Ingredient Strength0 mg/1; mg/1
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50419-482-03

3 BLISTER PACK in 1 CARTON (50419-482-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-482-71 [50419048271]

Angeliq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021355
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

NDC 50419-482-01 [50419048201]

Angeliq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021355
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29

NDC 50419-482-72 [50419048272]

Angeliq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021355
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

NDC 50419-482-03 [50419048203]

Angeliq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021355
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:761834c2-6b61-4583-84c2-f1ca4a97c4f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483549
  • 1483554
  • 1483551
  • 1483550
  • 1483553
  • 1483552
  • Pharmacological Class

    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "Angeliq" or generic name "Drospirenone And Estradiol"

    NDCBrand NameGeneric Name
    50419-482Angeliqdrospirenone and estradiol
    50419-483Angeliqdrospirenone and estradiol

    Trademark Results [Angeliq]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ANGELIQ
    ANGELIQ
    75698450 2687725 Live/Registered
    BAYER INTELLECTUAL PROPERTY GMBH
    1999-05-05

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