pemetrexed

Generic: pemetrexed disodium

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pemetrexed
Generic Name pemetrexed disodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pemetrexed disodium hemipentahydrate 100 mg/10mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-166
Product ID 71288-166_b38927c4-2b38-4d5c-be9f-86ba95ddc038
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208696
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 71288166
Hyphenated Format 71288-166

Supplemental Identifiers

RxCUI
1728072 1728077
UNII
F4GSH45R4C

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 ANDA208696 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-166-91 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

pemetrexed disodium hemipentahydrate (100 mg/10mL)

Linked Drug Pages (3)

Pemetrexed ndc-match (0.9) Pemetrexed ndc-match (0.9) Pemetrexed ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b38927c4-2b38-4d5c-be9f-86ba95ddc038", "openfda": {"unii": ["F4GSH45R4C"], "rxcui": ["1728072", "1728077"], "spl_set_id": ["e0d000a3-b9d2-4fa9-9591-f7acb077481d"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-166-91", "marketing_start_date": "20220525"}], "brand_name": "Pemetrexed", "product_id": "71288-166_b38927c4-2b38-4d5c-be9f-86ba95ddc038", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "71288-166", "generic_name": "Pemetrexed disodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE", "strength": "100 mg/10mL"}], "application_number": "ANDA208696", "marketing_category": "ANDA", "marketing_start_date": "20220525", "listing_expiration_date": "20261231"}