Home NDC 83831-123 AVGEMSI
Product NDC 83831-123
11-digit product format 838310123
Labeler code 83831
Product ID 83831-123_303c41a6-c142-4cd2-b133-9e610845d5bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemcitabine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA219920
Marketing category NDA
Marketing start 2025-08-03
Substance GEMCITABINE HYDROCHLORIDE
Active strength 38 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219920-001 AVGEMSI GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-06-27 N219920-002 AVGEMSI GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 N219920-003 AVGEMSI GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N219920-001 AVGEMSI EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219920-002 AVGEMSI EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219920-003 AVGEMSI EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219920-001 AVGEMSI EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219920-002 AVGEMSI EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219920-003 AVGEMSI EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219920-001 AVGEMSI EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219920-002 AVGEMSI EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219920-003 AVGEMSI EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219920-001 AVGEMSI EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219920-002 AVGEMSI EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219920-003 AVGEMSI EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219920-001 AVGEMSI EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219920-002 AVGEMSI EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219920-003 AVGEMSI EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-06-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base AVGEMSI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMCITABINE HYDROCHLORIDE 38 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U347PV74IL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2719761 Internal RxNorm lookup 2719763 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83831-123-01 AVGEMSI 26.3 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 26.3 3 83831-123-01 AVGEMSI 1 in 1 CARTON INJECTION, SOLUTION 1 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-123-01 83831012301 1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE 2025-08-03 No No Current