pemetrexed
Generic: pemetrexed disodium
Labeler: sandoz inc.Drug Facts
Product Profile
Brand Name
pemetrexed
Generic Name
pemetrexed disodium
Labeler
sandoz inc.
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
pemetrexed disodium 1000 mg/40mL
Manufacturer
Identifiers & Regulatory
Product NDC
0781-3520
Product ID
0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA214657
Listing Expiration
2026-12-31
Marketing Start
2022-06-08
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
07813520
Hyphenated Format
0781-3520
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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
NDA214657 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 1000 mg/40mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Pemetrexed Injection is supplied as a sterile single-dose vial containing clear colorless to yellow or green-yellow solution in a clear glass vial with a grey rubber closure, aluminum cap, and light blue flip-off cap Strength/Fill volume NDC number Pack style 100 mg/4 mL NDC 0781-3518-76 Carton containing one (1) single-dose vial 500 mg/20 mL NDC 0781-3519-90 Carton containing one (1) single-dose vial 1,000 mg/40 mL NDC 0781-3520-91 Carton containing one (1) single-dose vial Storage and Handling Store solution at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep the vial in the carton box until the time of use. Pemetrexed Injection is a hazardous drug. Follow applicable special handling and disposal procedures [see References ( 15 )]. 1
- Principal Display Panel – 4 mL NDC 0781-3518-76 Pemetrexed Injection 100 mg/4 mL (25 mg/mL) For Intravenous Infusion After Dilution Warning: Hazardous Drug Single-Dose Vial Discard unused Portion Rx Only Sterile SANDOZ 4ml-carton
- Principal Display Panel – 20 mL NDC 0781-3519-90 Pemetrexed Injection 500 mg/20 mL (25 mg/mL) For Intravenous Infusion After Dilution Warning: Hazardous Drug Single-Dose Vial Discard unused Portion. Rx Only Sterile SANDOZ 20ml-carton
- Principal Display Panel NDC 0781-3520-91 Pemetrexed Injection 1000 mg/40 mL (25 mg/mL) For Intravenous Infusion After Dilution Warning: Hazardous Drug Single-Dose Vial Discard unused Portion. Rx Only Sterile SANDOZ 40ml-carton
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "764ab64b-c642-4314-83a9-efee79fe83a3", "openfda": {"unii": ["2PKU919BA9"], "rxcui": ["2602363", "2602365", "2602366"], "spl_set_id": ["7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Pemetrexed", "product_id": "0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0781-3520", "generic_name": "Pemetrexed disodium", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED DISODIUM", "strength": "1000 mg/40mL"}], "application_number": "NDA214657", "marketing_category": "NDA", "marketing_start_date": "20220608", "listing_expiration_date": "20261231"}