gemcitabine hydrochloride

Generic: gemcitabine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine hydrochloride
Generic Name gemcitabine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 200 mg/5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-148
Product ID 68083-148_35c72954-279a-45fe-aa22-2b97e20b7b0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204520
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083148
Hyphenated Format 68083-148

Supplemental Identifiers

RxCUI
1719000 1719003
UPC
0368083148010 0368083149017
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 hydrochloride (source: ndc)
Generic Name gemcitabine hydrochloride (source: ndc)
Application Number ANDA204520 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68083-148-01 1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL

Ingredients (1)

gemcitabine hydrochloride (200 mg/5mL)

Linked Drug Pages (1)

gemcitabine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "35c72954-279a-45fe-aa22-2b97e20b7b0d", "openfda": {"upc": ["0368083148010", "0368083149017"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["9f8fe5ba-943f-4f0a-9618-6083101faa28"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-148-01)  / 5 mL in 1 VIAL", "package_ndc": "68083-148-01", "marketing_start_date": "20160201"}], "brand_name": "gemcitabine hydrochloride", "product_id": "68083-148_35c72954-279a-45fe-aa22-2b97e20b7b0d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-148", "generic_name": "gemcitabine hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gemcitabine hydrochloride", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5mL"}], "application_number": "ANDA204520", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}