gemcitabine

Generic: gemcitabine

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemcitabine
Generic Name gemcitabine
Labeler dr. reddy's laboratories limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 200 mg/5mL

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-686
Product ID 55111-686_12d7e1d6-334a-7d1c-2db2-ea73c496d9ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091365
Listing Expiration 2026-12-31
Marketing Start 2011-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111686
Hyphenated Format 55111-686

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 (source: ndc)
Application Number ANDA091365 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

55111-686-07 1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07) / 5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

gemcitabine hydrochloride (200 mg/5mL)

Linked Drug Pages (1)

gemcitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "12d7e1d6-334a-7d1c-2db2-ea73c496d9ff", "openfda": {"unii": ["U347PV74IL"], "rxcui": ["1719000", "1719003"], "spl_set_id": ["eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "55111-686-07", "marketing_start_date": "20110725"}], "brand_name": "gemcitabine", "product_id": "55111-686_12d7e1d6-334a-7d1c-2db2-ea73c496d9ff", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "55111-686", "generic_name": "gemcitabine", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gemcitabine", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "200 mg/5mL"}], "application_number": "ANDA091365", "marketing_category": "ANDA", "marketing_start_date": "20110725", "listing_expiration_date": "20261231"}