gemcitabine

Generic: gemcitabine

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0183
Product ID 0409-0183_949ef588-ec7f-4dce-964e-984cd6618423
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200795
Listing Expiration 2026-12-31
Marketing Start 2011-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090183
Hyphenated Format 0409-0183

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 (source: ndc)
Application Number NDA200795 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-01) / 5.26 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0409-0183-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-01) / 5.26 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (38 mg/mL)

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": "949ef588-ec7f-4dce-964e-984cd6618423", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["dc02a23b-3ff9-4441-aa91-8e9e629a7315"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-01)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-0183-01", "marketing_start_date": "20110824"}], "brand_name": "Gemcitabine", "product_id": "0409-0183_949ef588-ec7f-4dce-964e-984cd6618423", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0409-0183", "generic_name": "GEMCITABINE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "NDA200795", "marketing_category": "NDA", "marketing_start_date": "20110824", "listing_expiration_date": "20261231"}