gemcitabine

Generic: gemcitabine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 1 g/25mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-125
Product ID 63323-125_ce96743d-23fc-4de4-9df1-b650d64f4cbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090799
Listing Expiration 2026-12-31
Marketing Start 2011-07-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323125
Hyphenated Format 63323-125

Supplemental Identifiers

RxCUI
1719000 1719003 1719005
UPC
0363323125530 0363323126032 0363323102135
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 ANDA090799 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-125-53 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (1 g/25mL)

Linked Drug Pages (2)

GEMCITABINE ndc-match (0.9) GEMCITABINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ce96743d-23fc-4de4-9df1-b650d64f4cbc", "openfda": {"upc": ["0363323125530", "0363323126032", "0363323102135"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003", "1719005"], "spl_set_id": ["c550dd16-a5e8-44be-87f2-210c15bbb513"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-125-53", "marketing_start_date": "20110726"}], "brand_name": "GEMCITABINE", "product_id": "63323-125_ce96743d-23fc-4de4-9df1-b650d64f4cbc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-125", "generic_name": "GEMCITABINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "1 g/25mL"}], "application_number": "ANDA090799", "marketing_category": "ANDA", "marketing_start_date": "20110726", "listing_expiration_date": "20261231"}