pemetrexed

Generic: pemetrexed disodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pemetrexed
Generic Name pemetrexed disodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pemetrexed disodium 100 mg/4mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-134
Product ID 63323-134_c7ff62a1-e697-4a7c-9907-59163f393528
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090384
Listing Expiration 2026-12-31
Marketing Start 2022-05-25

Pharmacologic Class

Classes
folate analog metabolic inhibitor [epc] folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323134
Hyphenated Format 63323-134

Supplemental Identifiers

RxCUI
1728072 1728077 2601728 2602136
UPC
0363323450502 0363323622008 0363323621001 0363323134105
UNII
2PKU919BA9

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 pemetrexed (source: ndc)
Generic Name pemetrexed disodium (source: ndc)
Application Number ANDA090384 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/4mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

63323-134-10 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

pemetrexed disodium (100 mg/4mL)

Linked Drug Pages (1)

Pemetrexed ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c7ff62a1-e697-4a7c-9907-59163f393528", "openfda": {"upc": ["0363323450502", "0363323622008", "0363323621001", "0363323134105"], "unii": ["2PKU919BA9"], "rxcui": ["1728072", "1728077", "2601728", "2602136"], "spl_set_id": ["ae77f00f-d43b-4b75-afd5-a2a9cb7138da"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10)  / 4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "63323-134-10", "marketing_start_date": "20220525"}], "brand_name": "Pemetrexed", "product_id": "63323-134_c7ff62a1-e697-4a7c-9907-59163f393528", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "63323-134", "generic_name": "PEMETREXED DISODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED DISODIUM", "strength": "100 mg/4mL"}], "application_number": "ANDA090384", "marketing_category": "ANDA", "marketing_start_date": "20220525", "listing_expiration_date": "20261231"}