NDC 50419-491

Climara Pro

Estradiol And Levonorgestrel

Climara Pro is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Estradiol; Levonorgestrel.

• Product ID: 50419-491_0b8bb79e-b2b0-4018-bc26-d2974375f444
• NDC: 50419-491
• Product Type: Human Prescription Drug
• Proprietary Name: Climara Pro
• Generic Name: Estradiol And Levonorgestrel
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2003-11-21
• Marketing Category: NDA / NDA
• Application Number: NDA021258
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: ESTRADIOL; LEVONORGESTREL
• Active Ingredient Strength: 0 mg/d; mg/d
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50419-491-04

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

• Marketing Start Date: 2013-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-491-73 [50419049173]

Climara Pro PATCH

• Marketing Category: NDA
• Application Number: NDA021258
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-12

NDC 50419-491-04 [50419049104]

Climara Pro PATCH

• Marketing Category: NDA
• Application Number: NDA021258
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-11-21

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.045 mg/d

OpenFDA Data

• SPL SET ID: 184d3092-7fc6-4375-816b-1ab06bb99cfd
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • 4TI98Z838E
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 402250
  • 402252

Pharmacological Class

• Estradiol Congeners [CS]
• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]
• Inhibit Ovum Fertilization [PE]
• Progesterone Congeners [CS]
• Progesterone Congeners [CS]
• Progestin [EPC]
• Progestin-containing Intrauterine Device [EPC]

Medicade Reported Pricing

50419049104 CLIMARA PRO PATCH

Pricing Unit: EA | Drug Type: