gemcitabine

Generic: gemcitabine

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine
Labeler accord healthcare inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 100 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-391
Product ID 16729-391_22df64f5-26e2-6cf4-e063-6394a90aecf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209604
Listing Expiration 2026-12-31
Marketing Start 2018-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729391
Hyphenated Format 16729-391

Supplemental Identifiers

RxCUI
1998783
UPC
0316729426053 0316729419031 0316729423335 0316729391306
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
  • 2 mL in 1 VIAL, MULTI-DOSE (16729-391-30)
source: ndc

Packages (1)

16729-391-30 2 mL in 1 VIAL, MULTI-DOSE (16729-391-30)

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": "22df64f5-26e2-6cf4-e063-6394a90aecf0", "openfda": {"upc": ["0316729426053", "0316729419031", "0316729423335", "0316729391306"], "unii": ["U347PV74IL"], "rxcui": ["1998783"], "spl_set_id": ["5a335d36-408b-478f-9563-4bc140b69bb6"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, MULTI-DOSE (16729-391-30)", "package_ndc": "16729-391-30", "marketing_start_date": "20180124"}], "brand_name": "GEMCITABINE", "product_id": "16729-391_22df64f5-26e2-6cf4-e063-6394a90aecf0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "16729-391", "generic_name": "GEMCITABINE", "labeler_name": "Accord Healthcare Inc.", "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": "20180124", "listing_expiration_date": "20261231"}