avgemsi

Generic: gemcitabine

Labeler: avyxa pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name avgemsi
Generic Name gemcitabine
Labeler avyxa pharma, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gemcitabine hydrochloride 38 mg/mL

Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-124
Product ID 83831-124_303c41a6-c142-4cd2-b133-9e610845d5bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219920
Listing Expiration 2026-12-31
Marketing Start 2025-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83831124
Hyphenated Format 83831-124

Supplemental Identifiers

RxCUI
2719761 2719763
UPC
0383831124016
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 avgemsi (source: ndc)
Generic Name gemcitabine (source: ndc)
Application Number NDA219920 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 38 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

83831-124-01 1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

gemcitabine hydrochloride (38 mg/mL)

Linked Drug Pages (1)

AVGEMSI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "303c41a6-c142-4cd2-b133-9e610845d5bf", "openfda": {"upc": ["0383831124016"], "unii": ["U347PV74IL"], "rxcui": ["2719761", "2719763"], "spl_set_id": ["e11eeff7-bcaf-4bf1-8da8-88138e01af84"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01)  / 52.6 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "83831-124-01", "marketing_start_date": "20250803"}], "brand_name": "AVGEMSI", "product_id": "83831-124_303c41a6-c142-4cd2-b133-9e610845d5bf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "83831-124", "generic_name": "Gemcitabine", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AVGEMSI", "active_ingredients": [{"name": "GEMCITABINE HYDROCHLORIDE", "strength": "38 mg/mL"}], "application_number": "NDA219920", "marketing_category": "NDA", "marketing_start_date": "20250803", "listing_expiration_date": "20261231"}