NDC 72893-003

Folotyn

Pralatrexate

Folotyn is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Acrotech Biopharma Llc. The primary component is Pralatrexate.

• Product ID: 72893-003_192ac27b-5caa-4401-a06e-f168d5b8c5b6
• NDC: 72893-003
• Product Type: Human Prescription Drug
• Proprietary Name: Folotyn
• Generic Name: Pralatrexate
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA022468
• Labeler Name: Acrotech Biopharma LLC
• Substance Name: PRALATREXATE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Folate Analog Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 72893-003-01

1 VIAL in 1 CARTON (72893-003-01) > 1 mL in 1 VIAL

• Marketing Start Date: 2009-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72893-003-01 [72893000301]

Folotyn INJECTION

• Marketing Category: NDA
• Application Number: NDA022468
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-24

Drug Details

Active Ingredients

Ingredient	Strength
PRALATREXATE	20 mg/mL

OpenFDA Data

• SPL SET ID: 9f3d9c4d-9386-4451-b712-0fbdc5478d8f
• Manufacturer:
  • Acrotech Biopharma LLC
• UNII:
  • A8Q8I19Q20
• RxNorm Concept Unique ID - RxCUI:
  • 1796419
  • 1796421
  • 1796424
  • 1796425

Pharmacological Class

• Folate Analog Metabolic Inhibitor [EPC]
• Folate Analog Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Folotyn" or generic name "Pralatrexate"

NDC	Brand Name	Generic Name
48818-001	Folotyn	pralatrexate
72893-003	Folotyn	pralatrexate
72893-005	Folotyn	pralatrexate
65219-550	Pralatrexate	Pralatrexate
65219-552	Pralatrexate	Pralatrexate