gemcitabine hydrochloride

Generic: gemcitabine hydrochloride

Labeler: teyro labs private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine hydrochloride
Generic Name gemcitabine hydrochloride
Labeler teyro labs private limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 1 g/25mL

Manufacturer
Teyro Labs Private Limited

Identifiers & Regulatory

Product NDC 82511-009
Product ID 82511-009_2b407956-8a90-221c-e063-6394a90a0057
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078759
Listing Expiration 2026-12-31
Marketing Start 2024-08-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82511009
Hyphenated Format 82511-009

Supplemental Identifiers

RxCUI
1719000 1719003
UPC
0382511008202
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 ANDA078759 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (82511-009-10) / 25 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

82511-009-10 1 VIAL, SINGLE-USE in 1 CARTON (82511-009-10) / 25 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

gemcitabine hydrochloride (1 g/25mL)

Linked Drug Pages (1)

Gemcitabine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2b407956-8a90-221c-e063-6394a90a0057", "openfda": {"upc": ["0382511008202"], "unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["a6ddaa2f-4c17-430f-a7cd-96b6662923f6"], "manufacturer_name": ["Teyro Labs Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (82511-009-10)  / 25 mL in 1 VIAL, SINGLE-USE", "package_ndc": "82511-009-10", "marketing_start_date": "20240808"}], "brand_name": "Gemcitabine hydrochloride", "product_id": "82511-009_2b407956-8a90-221c-e063-6394a90a0057", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "82511-009", "generic_name": "Gemcitabine hydrochloride", "labeler_name": "Teyro Labs Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gemcitabine hydrochloride", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "1 g/25mL"}], "application_number": "ANDA078759", "marketing_category": "ANDA", "marketing_start_date": "20240808", "listing_expiration_date": "20261231"}