gemcitabine

Generic: gemcitabine hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 200 mg/5.26mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-616
Product ID 67457-616_93d514c4-a877-475d-91e0-9cfb232d55ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205242
Listing Expiration 2026-12-31
Marketing Start 2018-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457616
Hyphenated Format 67457-616

Supplemental Identifiers

RxCUI
1720960 1720975 1720977
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 hydrochloride (source: ndc)
Application Number ANDA205242 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/5.26mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-616-10 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (200 mg/5.26mL)

Linked Drug Pages (1)

Gemcitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "93d514c4-a877-475d-91e0-9cfb232d55ca", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["06dd9d40-74fc-4409-93b1-a46be7126331"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-616-10", "marketing_start_date": "20180103"}], "brand_name": "Gemcitabine", "product_id": "67457-616_93d514c4-a877-475d-91e0-9cfb232d55ca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "67457-616", "generic_name": "GEMCITABINE HYDROCHLORIDE", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5.26mL"}], "application_number": "ANDA205242", "marketing_category": "ANDA", "marketing_start_date": "20180103", "listing_expiration_date": "20261231"}