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 2 g/50mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-126
Product ID 63323-126_9a2f8c36-ae77-4e75-88ba-dad480706226
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090242
Listing Expiration 2026-12-31
Marketing Start 2011-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323126
Hyphenated Format 63323-126

Supplemental Identifiers

RxCUI
1719005
UPC
0363323126001
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 ANDA090242 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/50mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 200 mg, 1 g or 2 g gemcitabine: Product Code Unit of Sale Strength FK101210 NDC 63323-102-13 Individually packaged 200 mg per vial FK102550 NDC 63323-125-53 Individually packaged 1 gram per vial FK102600 NDC 63323-126-03 Individually packaged 2 grams per vial Gemcitabine for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 200mg-Vial Carton NDC: 63323-102-13 FK101210 GEMCITABINE FOR INJECTION, USP 200 mg per vial For Intravenous use only Must Be Diluted DO NOT REFRIGERATE Cytotoxic Agent Rx only Single-Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 200 mg- Vial Label NDC: 63323-102-13 FK101210 GEMCITABINE FOR INJECTION, USP 200 mg per vial For Intravenous use only Must Be Diluted Rx only Single-Dose Vial 200mg vial-200mg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 1g-Vial Carton NDC 63323-125-53 FK102550 GEMCITABINE FOR INJECTION, USP 1 g per vial For Intravenous use only Must Be Diluted DO NOT REFRIGERATE Cytotoxic Agent Rx only Single-Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 1 g- Vial Label NDC 63323-125-53 FK102550 GEMCITABINE FOR INJECTION, USP 1 g per vial For Intravenous use only Must Be Diluted Rx only Single-Dose Vial carton-1g vial-1g
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 2g-Vial Carton NDC 63323-126-03 FK102600 GEMCITABINE FOR INJECTION, USP 2 g per vial For Intravenous use only Must Be Diluted DO NOT REFRIGERATE Cytotoxic Agent Rx only Single-Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Gemcitabine 2 g- Vial Label NDC 63323-126-03 FK102600 GEMCITABINE FOR INJECTION, USP 2 g per vial For Intravenous use only Must Be Diluted Rx only Single-Dose Vial carton-2g vial-2g
source: label

Packages (0)

No package records.

Ingredients (1)

gemcitabine hydrochloride (2 g/50mL)

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": "9a2f8c36-ae77-4e75-88ba-dad480706226", "openfda": {"upc": ["0363323126001"], "unii": ["U347PV74IL"], "rxcui": ["1719005"], "spl_set_id": ["b9347b14-7ca2-43f5-9ee8-7ba709ae6b52"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "GEMCITABINE", "product_id": "63323-126_9a2f8c36-ae77-4e75-88ba-dad480706226", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-126", "generic_name": "GEMCITABINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "2 g/50mL"}], "application_number": "ANDA090242", "marketing_category": "ANDA", "marketing_start_date": "20110517", "listing_expiration_date": "20261231"}