gemcitabine

Generic: gemcitabine

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

Drug Facts

Product Profile

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

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-239
Product ID 25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209077
Listing Expiration 2026-12-31
Marketing Start 2019-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021239
Hyphenated Format 25021-239

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 ANDA209077 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIAL
source: ndc

Packages (3)

25021-239-05 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL 25021-239-26 1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIAL 25021-239-52 1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIAL

Ingredients (1)

gemcitabine hydrochloride (38 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": "adf9b715-8cef-4a0d-ba30-d948b2b04272", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["22af3507-4b4f-4cad-9d61-89ffc4aabbc7"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-239-05)  / 5.26 mL in 1 VIAL", "package_ndc": "25021-239-05", "marketing_start_date": "20190115"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-239-26)  / 26.3 mL in 1 VIAL", "package_ndc": "25021-239-26", "marketing_start_date": "20190115"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-239-52)  / 52.6 mL in 1 VIAL", "package_ndc": "25021-239-52", "marketing_start_date": "20190115"}], "brand_name": "Gemcitabine", "product_id": "25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "25021-239", "generic_name": "gemcitabine", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA209077", "marketing_category": "ANDA", "marketing_start_date": "20190115", "listing_expiration_date": "20261231"}