zepzelca

Generic: lurbinectedin

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zepzelca
Generic Name lurbinectedin
Labeler jazz pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lurbinectedin .5 mg/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-712
Product ID 68727-712_70beec73-1432-4a8c-92fb-1aa1ed06e34c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213702
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727712
Hyphenated Format 68727-712

Supplemental Identifiers

RxCUI
2374733 2374738
UNII
2CN60TN6ZS
NUI
N0000000236 N0000175558

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 zepzelca (source: ndc)
Generic Name lurbinectedin (source: ndc)
Application Number NDA213702 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)
source: ndc

Packages (1)

68727-712-01 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)

Ingredients (1)

lurbinectedin (.5 mg/mL)

Linked Drug Pages (1)

ZEPZELCA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "70beec73-1432-4a8c-92fb-1aa1ed06e34c", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["2CN60TN6ZS"], "rxcui": ["2374733", "2374738"], "spl_set_id": ["632bb50c-3bcb-4c85-9056-fc33410550ae"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)", "package_ndc": "68727-712-01", "marketing_start_date": "20200615"}], "brand_name": "ZEPZELCA", "product_id": "68727-712_70beec73-1432-4a8c-92fb-1aa1ed06e34c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68727-712", "generic_name": "Lurbinectedin", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEPZELCA", "active_ingredients": [{"name": "LURBINECTEDIN", "strength": ".5 mg/mL"}], "application_number": "NDA213702", "marketing_category": "NDA", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}