FDA.reportPublic FDA data

NDC 63323-173-01 - Gentamicin

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
63323-173
Requested NDC
63323-173-01
Package NDCs from labels
63323-173-95, 63323-173-41, 63323-173-94, 63323-173-01, 63323-173-02
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-14HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-12-20HUMAN PRESCRIPTION DRUG LABEL
Gentamicin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-10-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-173-01Gentamicin2 mL in 1 VIALINJECTION, SOLUTION28
63323-173-02Gentamicin25 in 1 TRAYINJECTION, SOLUTION258
63323-173-41Gentamicin2 mL in 1 VIALINJECTION, SOLUTION24
63323-173-94Gentamicin25 in 1 TRAYINJECTION, SOLUTION254
63323-173-95Gentamicin25 in 1 TRAYINJECTION, SOLUTION253
63323-173-95Gentamicin2 mL in 1 VIALINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20231215_be5b414e-d598-4721-80ee-5836156ad210.zip
63323-173GENTAMICIN (GENTAMICIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20240106_8bdeef7f-ad8e-46e0-a872-e945eae51d68.zip
63323-173GENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241017_63413469-c676-48a3-a945-7d2489b535ef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-173-01ML - Milliliter63323-173ced61a19-c526-4301-9865-ba40e8c2182012022-08-04
63323-173-02ML - Milliliter63323-1735fd11ec3-8c33-4c79-b4c7-bec645fb287312012-07-24
63323-173-41ML - Milliliter63323-173d5f59524-b9ee-4918-b264-40afffbbcc2e12023-01-09
63323-173-94ML - Milliliter63323-17353fc2922-96f5-4ce1-8684-be9e028a9a6e12013-12-02
63323-173-95ML - Milliliter63323-173f3a52ac6-ae2b-4af9-8def-100e9d3032b712014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 4 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: O40UQP6WCF
SlenderiixWEIGHT MANAGEMENT FORMULAVitality Works398251ec-6834-4dda-abc6-f503632d16322025-12-17WarningsExact identifier
unii: O40UQP6WCF
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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