pralatrexate

Generic: pralatrexate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name pralatrexate
Generic Name pralatrexate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

pralatrexate 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-550
Product ID 65219-550_510bc71b-20e4-428a-8fc2-29c9fc20f2f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022468
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219550
Hyphenated Format 65219-550

Supplemental Identifiers

RxCUI
1796419 1796424
UNII
A8Q8I19Q20
NUI
N0000175584

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pralatrexate (source: ndc)
Generic Name pralatrexate (source: ndc)
Application Number NDA022468 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65219-550-01 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

pralatrexate (20 mg/mL)

Linked Drug Pages (1)

Pralatrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "510bc71b-20e4-428a-8fc2-29c9fc20f2f3", "openfda": {"nui": ["N0000175584"], "unii": ["A8Q8I19Q20"], "rxcui": ["1796419", "1796424"], "spl_set_id": ["a5daa583-4965-4564-ad87-41ffe6c08a11"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65219-550-01", "marketing_start_date": "20221115"}], "brand_name": "Pralatrexate", "product_id": "65219-550_510bc71b-20e4-428a-8fc2-29c9fc20f2f3", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]"], "product_ndc": "65219-550", "generic_name": "Pralatrexate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pralatrexate", "active_ingredients": [{"name": "PRALATREXATE", "strength": "20 mg/mL"}], "application_number": "NDA022468", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}