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 ID: 50419-482_5a4eb954-8197-4c51-aaf7-81b1956c3c23
• NDC: 50419-482
• Product Type: Human Prescription Drug
• Proprietary Name: Angeliq
• Generic Name: Drospirenone And Estradiol
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-29
• Marketing Category: NDA / NDA
• Application Number: NDA021355
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: DROSPIRENONE; ESTRADIOL
• Active Ingredient Strength: 0 mg/1; mg/1
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

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 Date: 2012-02-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-482-71 [50419048271]

Angeliq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021355
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-02-29

NDC 50419-482-01 [50419048201]

Angeliq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021355
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-29

NDC 50419-482-72 [50419048272]

Angeliq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021355
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-02-29

NDC 50419-482-03 [50419048203]

Angeliq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021355
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-29

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.5 mg/1

OpenFDA Data

• SPL SET ID: 761834c2-6b61-4583-84c2-f1ca4a97c4f2
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 4TI98Z838E
  • N295J34A25
• 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"

NDC	Brand Name	Generic Name
50419-482	Angeliq	drospirenone and estradiol
50419-483	Angeliq	drospirenone and estradiol