NDC 69413-330

Daraprim

Pyrimethamine

Daraprim is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Vyera Pharmaceuticals Llc. The primary component is Pyrimethamine.

• Product ID: 69413-330_38325135-541d-4fc0-bef8-88be76fb3425
• NDC: 69413-330
• Product Type: Human Prescription Drug
• Proprietary Name: Daraprim
• Generic Name: Pyrimethamine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1953-01-23
• Marketing Category: NDA / NDA
• Application Number: NDA008578
• Labeler Name: Vyera Pharmaceuticals LLC
• Substance Name: PYRIMETHAMINE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69413-330-10

100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10)

• Marketing Start Date: 1953-01-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69413-330-10 [69413033010]

Daraprim TABLET

• Marketing Category: NDA
• Application Number: NDA008578
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1953-01-23

NDC 69413-330-30 [69413033030]

Daraprim TABLET

• Marketing Category: NDA
• Application Number: NDA008578
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1953-01-23

NDC 69413-330-06 [69413033006]

Daraprim TABLET

• Marketing Category: NDA
• Application Number: NDA008578
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1953-01-23
• Marketing End Date: 2019-10-01

Drug Details

Active Ingredients

Ingredient	Strength
PYRIMETHAMINE	25 mg/1

OpenFDA Data

• SPL SET ID: 5368616d-6520-6f6e-2053-686b72656c69
• Manufacturer:
  • Vyera Pharmaceuticals LLC
• UNII:
  • Z3614QOX8W
• RxNorm Concept Unique ID - RxCUI:
  • 201912
  • 198182
• UPC Code:
  • 0369413330105
  • 0369413330068
  • 0369413330303

Pharmacological Class

• Dihydrofolate Reductase Inhibitor Antimalarial [EPC]
• Dihydrofolate Reductase Inhibitors [MoA]

NDC Crossover Matching brand name "Daraprim" or generic name "Pyrimethamine"

NDC	Brand Name	Generic Name
69413-330	Daraprim	pyrimethamine
0480-3720	Pyrimethamine	Pyrimethamine
43598-672	Pyrimethamine	pyrimethamine
47781-925	pyrimethamine	pyrimethamine
48102-026	Pyrimethamine	PYRIMETHAMINE
59651-590	Pyrimethamine	Pyrimethamine
72647-330	Pyrimethamine	pyrimethamine