FDA.reportPublic FDA data

NDC 63323-624-05 - Dextrose

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-624
Requested NDC
63323-624-05
Package NDCs from labels
63323-624-05, 63323-624-50, 63323-624-06, 63323-624-61, 63323-624-04, 63323-624-74, 63323-624-07, 63323-624-75, 63323-624-03, 63323-624-10
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbH | HP Halden Pharma AS
Effective date
2024-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
5% Dextrose Injection, USPFresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbH | HP Halden Pharma AS2024-04-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-624-03Dextrose1000 mL in 1 BAGINJECTION, SOLUTION10007
63323-624-04Dextrose250 mL in 1 BAGINJECTION, SOLUTION2507
63323-624-05Dextrose50 mL in 1 BAGINJECTION, SOLUTION507
63323-624-06Dextrose100 mL in 1 BAGINJECTION, SOLUTION1007
63323-624-07Dextrose500 mL in 1 BAGINJECTION, SOLUTION5007
63323-624-10Dextrose10 in 1 CASEINJECTION, SOLUTION107
63323-624-50Dextrose60 in 1 CASEINJECTION, SOLUTION607
63323-624-61Dextrose50 in 1 CASEINJECTION, SOLUTION507
63323-624-74Dextrose30 in 1 CASEINJECTION, SOLUTION307
63323-624-75Dextrose20 in 1 CASEINJECTION, SOLUTION207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-624DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 10 package rows20240427_f2379398-a07b-417e-a022-f7b41f962067.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-624-03ML - Milliliter63323-6244fb0b62e-c170-41e3-8d55-d6686d07255312025-01-14
63323-624-04ML - Milliliter63323-624ba451c15-d000-40d8-9ec2-6db27b773b5112020-08-06
63323-624-05ML - Milliliter63323-62433091252-80e7-492f-ba23-0be7b1d8c39f12019-12-10
63323-624-06ML - Milliliter63323-6243ee3424e-6480-4d76-871b-ab4784f1fbfc12020-08-06
63323-624-07ML - Milliliter63323-624f7722f8f-0f2f-4987-9bfc-d332eb0817a812022-07-06
63323-624-10ML - Milliliter63323-62445426336-b95c-4b96-a8ab-332e39fe707612017-07-07
63323-624-50ML - Milliliter63323-624d4c7bafa-ccd8-4dc3-8a91-bc61ed75c61312019-12-10
63323-624-61ML - Milliliter63323-62473465176-b942-4554-9c19-8b18e365583712017-10-13
63323-624-74ML - Milliliter63323-62431e4494f-ab9f-42cf-aa90-b0c1859aef5112017-05-04
63323-624-75ML - Milliliter63323-624af12bccc-8f36-4e89-8020-20faa4cb4c3412017-05-04

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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Infant DextroseDEXTROSEHenry Schein, Inc.ce71d929-d11e-444c-bd45-e025d51720572026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 1795616
rxcui: 1795607
rxcui: 1795612
rxcui: 1795609
rxcui: 1795610
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1795616
rxcui: 1795609
rxcui: 1795610
unii: LX22YL083G
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSEB. Braun Medical Inc.60b6d7c3-0164-46c9-aa38-b5aa1c31a5d52026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 1795616
rxcui: 1795609
unii: LX22YL083G
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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