pralatrexate

Generic: pralatrexate

Labeler: dr.reddy's laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pralatrexate
Generic Name pralatrexate
Labeler dr.reddy's laboratories inc.,
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

pralatrexate 20 mg/mL

Manufacturer
Dr.Reddy's Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-342
Product ID 43598-342_b885a7b3-a241-638d-8f27-d162c562469a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206183
Listing Expiration 2027-12-31
Marketing Start 2026-03-04

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598342
Hyphenated Format 43598-342

Supplemental Identifiers

RxCUI
1796419 1796424
UPC
0343598342115 0343598343235
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 ANDA206183 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

43598-342-11 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 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": "b885a7b3-a241-638d-8f27-d162c562469a", "openfda": {"nui": ["N0000175584"], "upc": ["0343598342115", "0343598343235"], "unii": ["A8Q8I19Q20"], "rxcui": ["1796419", "1796424"], "spl_set_id": ["cc3df863-c51c-49c5-283a-d6808fb49258"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-342-11", "marketing_start_date": "20260304"}], "brand_name": "Pralatrexate", "product_id": "43598-342_b885a7b3-a241-638d-8f27-d162c562469a", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]"], "product_ndc": "43598-342", "generic_name": "Pralatrexate", "labeler_name": "Dr.Reddy's Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pralatrexate", "active_ingredients": [{"name": "PRALATREXATE", "strength": "20 mg/mL"}], "application_number": "ANDA206183", "marketing_category": "ANDA", "marketing_start_date": "20260304", "listing_expiration_date": "20271231"}