FDA.reportPublic FDA data

NDC 63323-869-01 - Dextrose and Sodium Chloride

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
63323-869
Requested NDC
63323-869-01
Package NDCs from labels
63323-869-05, 63323-869-75, 63323-869-04, 63323-869-74, 63323-869-01, 63323-869-10
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbH
Effective date
2024-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTROSE MONOHYDRATE - Fresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbHFresenius Kabi USA, LLC | Fresenius Kabi Deutschland GmbH2024-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-869-01Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10003
63323-869-04Dextrose and Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION5003
63323-869-05Dextrose and Sodium Chloride250 mL in 1 BAGINJECTION, SOLUTION2503
63323-869-10Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION103
63323-869-74Dextrose and Sodium Chloride20 in 1 CASEINJECTION, SOLUTION203
63323-869-75Dextrose and Sodium Chloride30 in 1 CASEINJECTION, SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-869DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 6 package rows20241010_3c5f0f65-8a54-4a55-ad4e-0f0be97631d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-869-01ML - Milliliter63323-869eb654ef4-bbe3-42a8-94a5-2077d3fa89e412025-06-13
63323-869-04ML - Milliliter63323-869eea56f3b-0208-4455-b48d-ed9bfd59c96d12025-11-13
63323-869-10ML - Milliliter63323-8696f2f203c-547d-46d1-a1e2-fc5323f4e3a012021-05-05
63323-869-74ML - Milliliter63323-8694cb5030b-9fd4-4baf-94d1-6d02faede6b812021-05-05
63323-869-75ML - Milliliter63323-869f7762f32-300c-4206-a80c-c9a13588bbe212021-05-05

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 56 · 1,109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anpitua StimADRENOCORTICOTROPHIN, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, LAC CANINUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM SUIS,J and Health DBA Wise Alternativec96d09bc-eaf7-4977-8f22-68246839f37d2026-08-05WarningsExact identifier
unii: 451W47IQ8X
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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: 451W47IQ8X
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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