gemcitabine

Generic: gemcitabine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 1 g/25mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-235
Product ID 25021-235_595a8cf5-412a-482d-8d77-979741ee4912
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202485
Listing Expiration 2026-12-31
Marketing Start 2014-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021235
Hyphenated Format 25021-235

Supplemental Identifiers

RxCUI
1719000 1719003
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 ANDA202485 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/25mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIAL
source: ndc

Packages (2)

25021-235-50 1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIAL 25021-235-51 10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIAL

Ingredients (1)

gemcitabine hydrochloride (1 g/25mL)

Linked Drug Pages (1)

gemcitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "595a8cf5-412a-482d-8d77-979741ee4912", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["44bcc16c-341d-49e8-a1c6-95d084667aca"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-235-50)  / 25 mL in 1 VIAL", "package_ndc": "25021-235-50", "marketing_start_date": "20141229"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-235-51)  / 25 mL in 1 VIAL", "package_ndc": "25021-235-51", "marketing_start_date": "20221215"}], "brand_name": "gemcitabine", "product_id": "25021-235_595a8cf5-412a-482d-8d77-979741ee4912", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "25021-235", "generic_name": "gemcitabine hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "1 g/25mL"}], "application_number": "ANDA202485", "marketing_category": "ANDA", "marketing_start_date": "20141229", "listing_expiration_date": "20261231"}