gemcitabine

Generic: gemcitabine

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-498
Product ID 50742-498_fbfd32c8-27e6-4f09-a09c-5fce401b87c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210383
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742498
Hyphenated Format 50742-498

Supplemental Identifiers

RxCUI
1720960 1720975 1720977
UPC
0350742496266 0350742498055 0350742497539
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 ANDA210383 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05) / 5.26 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50742-498-05 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05) / 5.26 mL in 1 VIAL, SINGLE-DOSE

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": "fbfd32c8-27e6-4f09-a09c-5fce401b87c1", "openfda": {"upc": ["0350742496266", "0350742498055", "0350742497539"], "unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["a15f5d83-6ba1-4891-9e26-ce23ddaf68c7"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05)  / 5.26 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50742-498-05", "marketing_start_date": "20230701"}], "brand_name": "GEMCITABINE", "product_id": "50742-498_fbfd32c8-27e6-4f09-a09c-5fce401b87c1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "50742-498", "generic_name": "gemcitabine", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA210383", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}