gemcitabine

Generic: gemcitabine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine
Labeler bluepoint laboratories
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 100 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-359
Product ID 68001-359_049982fe-a321-b868-e063-6294a90ae861
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209604
Listing Expiration 2026-12-31
Marketing Start 2018-05-25

Pharmacologic Class

Classes
nucleic acid synthesis inhibitors [moa] nucleoside metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001359
Hyphenated Format 68001-359

Supplemental Identifiers

RxCUI
1998783
UPC
0368001342346 0368001348362 0368001359375 0368001350686
UNII
U347PV74IL

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 gemcitabine (source: ndc)
Generic Name gemcitabine (source: ndc)
Application Number NDA209604 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68001-359-37 1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

gemcitabine hydrochloride (100 mg/mL)

Linked Drug Pages (1)

GEMCITABINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "049982fe-a321-b868-e063-6294a90ae861", "openfda": {"upc": ["0368001342346", "0368001348362", "0368001359375", "0368001350686"], "unii": ["U347PV74IL"], "rxcui": ["1998783"], "spl_set_id": ["4031017d-d768-46de-8081-476bcb883f5e"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68001-359-37", "marketing_start_date": "20180525"}], "brand_name": "GEMCITABINE", "product_id": "68001-359_049982fe-a321-b868-e063-6294a90ae861", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68001-359", "generic_name": "GEMCITABINE", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "NDA209604", "marketing_category": "NDA", "marketing_start_date": "20180525", "listing_expiration_date": "20261231"}