gemcitabine

Generic: gemcitabine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9342
Product ID 0143-9342_e9bd951d-0a47-409c-aa7c-2df9157d94e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213175
Listing Expiration 2026-12-31
Marketing Start 2025-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439342
Hyphenated Format 0143-9342

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 ANDA213175 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9342-01) / 52.6 mL in 1 VIAL
source: ndc

Packages (1)

0143-9342-01 1 VIAL in 1 CARTON (0143-9342-01) / 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": "e9bd951d-0a47-409c-aa7c-2df9157d94e2", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1720960", "1720975", "1720977"], "spl_set_id": ["d80176fe-3e8b-48be-87c2-9c603013b3fa"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9342-01)  / 52.6 mL in 1 VIAL", "package_ndc": "0143-9342-01", "marketing_start_date": "20251017"}], "brand_name": "Gemcitabine", "product_id": "0143-9342_e9bd951d-0a47-409c-aa7c-2df9157d94e2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0143-9342", "generic_name": "Gemcitabine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "ANDA213175", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}