FDA.reportPublic FDA data

Gemcitabine for Cheplapharm, QA383ESALE

Manufacturer
Evonik Corporation
Effective date
2026-09-09
Label type
BULK INGREDIENT
Version
10
Source
daily-update
Hydrated at
2026-09-22 03:03:13

Label at a glance#

ProductGemcitabine hydrochloride
Active ingredientGEMCITABINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Shipping Nice Label on Outer drum. Sept 2026.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk for Export Only

Caution: For Manufacturing, processing or repacking. Rx Only.

Gemcitabine Hydrochloride

QA383ESALE

99176150

Caution: Toxic, skin permeable, mutagen, irritant (eyes), reproductive, and blood.

Storage Conditions: 8 to 40°C

Batch number:

Manufacture date:

Manufactured and tested by Evonik Corporation, Tippecanoe Laboratories, 1650 Lilly Road, Lafayette, IN 47909

Shipping Label Sept 2026Shipping Label Sept 2026

Warehouse KG label, QA383ESALE, Sept 2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gemcitabine Hydrochloride GMP

Put-Away Label

Material Number 99176150

Storage Unit Number

Net Weight xx Kg

Lot/Batch

Old Material Number QA383ESALE

QR code box

Storage Conditions: Warehouse temperature

Temperature Conditions: 8°C - 40°C

Skin permeable. Mutagen. Irritant (eyes). Reproductive. Blood.

Highly potent. Acute toxicity, oral. Acute toxicity, dermal.

Health 2

Fire 1

Reactivity 1

Special R (reproductive hazard)

Evonik Corporation

1650 Lilly Road Lafayette, Indiana 47909 USA

Phone: 765-477-4300 Fax: 765-477-4291

Evonik: Leading beyond Chemistry

Emergency Phones:

(Chemtrec 24 h) US & CA 800-424-9300

Mexico 800-681-9531 / Intl. 001-703-527-3887 (collect calls accepted)

Warehouse Putaway LabelWarehouse Putaway Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeQR CodeC010199176150|033720028226|105046042025|968.100|97KGQA383ESALE_WarehouseLabel_Final.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a2b7d477-0e35-4772-8a9d-99c71e3e210bProduct name220190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067aProduct name520190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6Product name120180829
d2980057-8cff-4896-979e-b4c394974cfdProduct name120170829

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62128-038362128-0383-1, 62128-0383-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
GEMCITABINE HYDROCHLORIDEU347PV74ILACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-06-27full-release2026-06-01 02:51:49

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.c0b1b715-9ff8-43ca-9e49-465f1f3800842025-07-23Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINEGEMCITABINE HYDROCHLORIDENorthStar Rx LLC5af49a48-f1c0-467d-b5da-ac9f1ae8e34c2025-02-03Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINEGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.a5949d02-29eb-4626-ad35-b7614bb0fa952025-01-29Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine hydrochlorideGEMCITABINE HYDROCHLORIDETeyro Labs Private Limiteda6ddaa2f-4c17-430f-a7cd-96b6662923f62025-01-09Warnings, Adverse reactionsName fallback
brand name: Gemcitabine hydrochloride
generic name: GEMCITABINE HYDROCHLORIDE
GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLC06dd9d40-74fc-4409-93b1-a46be71263312024-11-11Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochlorideGEMCITABINE HYDROCHLORIDEGland Pharma Limited9f8fe5ba-943f-4f0a-9618-6083101faa282024-09-06Warnings, Adverse reactionsName fallback
brand name: gemcitabine hydrochloride
generic name: GEMCITABINE HYDROCHLORIDE
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.73ae04d8-38f9-4d3d-b0c2-71d22af1fc862024-08-05Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.