NDC 48818-001

Folotyn

Pralatrexate

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

• Product ID: 48818-001_1ed02005-69ec-499f-bf23-3100b06651f8
• NDC: 48818-001
• 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: Allos Therapeutics
• Substance Name: PRALATREXATE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Folate Analog Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 48818-001-01

1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-09-24
• Marketing End Date: 2023-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 48818-001-01 [48818000101]

Folotyn INJECTION

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

NDC 48818-001-02 [48818000102]

Folotyn INJECTION

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

Drug Details

Active Ingredients

Ingredient	Strength
PRALATREXATE	20 mg/mL

OpenFDA Data

• SPL SET ID: 5e4cf15b-bf7b-4b83-863e-e9ef27741a51
• Manufacturer:
  • Allos Therapeutics
• 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