gemcitabine

Generic: gemcitabine hydrochloride

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

Drug Facts

Product Profile

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

gemcitabine hydrochloride 200 mg/1

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-113
Product ID 71288-113_b696b925-51e8-48a8-881e-ae0a0373b3c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091365
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288113
Hyphenated Format 71288-113

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 ANDA091365 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-113-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gemcitabine hydrochloride (200 mg/1)

Linked Drug Pages (1)

GEMCITABINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b696b925-51e8-48a8-881e-ae0a0373b3c2", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["a5949d02-29eb-4626-ad35-b7614bb0fa95"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-113-10", "marketing_start_date": "20181101"}], "brand_name": "GEMCITABINE", "product_id": "71288-113_b696b925-51e8-48a8-881e-ae0a0373b3c2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-113", "generic_name": "GEMCITABINE HYDROCHLORIDE", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMCITABINE", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA091365", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}