folotyn

Generic: pralatrexate

Labeler: acrotech biopharma inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name folotyn
Generic Name pralatrexate
Labeler acrotech biopharma inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

pralatrexate 20 mg/mL

Manufacturer
Acrotech Biopharma Inc

Identifiers & Regulatory

Product NDC 72893-003
Product ID 72893-003_08d15e08-706e-4f2c-af12-bee22e1b8251
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022468
Listing Expiration 2026-12-31
Marketing Start 2009-09-24

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72893003
Hyphenated Format 72893-003

Supplemental Identifiers

RxCUI
1796419 1796421 1796424 1796425
UPC
0072893003017 0072893005011
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 folotyn (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 in 1 CARTON (72893-003-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

pralatrexate (20 mg/mL)

Linked Drug Pages (1)

Folotyn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "08d15e08-706e-4f2c-af12-bee22e1b8251", "openfda": {"nui": ["N0000175584"], "upc": ["0072893003017", "0072893005011"], "unii": ["A8Q8I19Q20"], "rxcui": ["1796419", "1796421", "1796424", "1796425"], "spl_set_id": ["9f3d9c4d-9386-4451-b712-0fbdc5478d8f"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "manufacturer_name": ["Acrotech Biopharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (72893-003-01)  / 1 mL in 1 VIAL", "package_ndc": "72893-003-01", "marketing_start_date": "20090924"}], "brand_name": "Folotyn", "product_id": "72893-003_08d15e08-706e-4f2c-af12-bee22e1b8251", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]"], "product_ndc": "72893-003", "generic_name": "pralatrexate", "labeler_name": "Acrotech Biopharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Folotyn", "active_ingredients": [{"name": "PRALATREXATE", "strength": "20 mg/mL"}], "application_number": "NDA022468", "marketing_category": "NDA", "marketing_start_date": "20090924", "listing_expiration_date": "20261231"}