NDC 76336-455

Metopirone

Metyrapone

Metopirone is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Hra Pharma Rare Diseases. The primary component is Metyrapone.

• Product ID: 76336-455_017dc211-d71d-4530-b856-5e3edcce0037
• NDC: 76336-455
• Product Type: Human Prescription Drug
• Proprietary Name: Metopirone
• Generic Name: Metyrapone
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-14
• Marketing Category: NDA / NDA
• Application Number: NDA012911
• Labeler Name: HRA Pharma Rare Diseases
• Substance Name: METYRAPONE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Adrenal Steroid Synthesis Inhibitor [EPC],Adrenal Steroid Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 76336-455-18

18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)

• Marketing Start Date: 2014-08-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76336-455-17 [76336045517]

Metopirone CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA012911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-01
• Marketing End Date: 2014-08-08

NDC 76336-455-18 [76336045518]

Metopirone CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA012911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-14

Drug Details

Active Ingredients

Ingredient	Strength
METYRAPONE	250 mg/1

OpenFDA Data

• SPL SET ID: 3a27d0ef-83a7-4e1c-9430-46a3326ee8d8
• Manufacturer:
  • Laboratoire HRA Pharma
• UNII:
  • ZS9KD92H6V
• RxNorm Concept Unique ID - RxCUI:
  • 105450
  • 199772

Pharmacological Class

• Adrenal Steroid Synthesis Inhibitor [EPC]
• Adrenal Steroid Synthesis Inhibitors [MoA]