NDC 0409-1207-13 - Gentamicin Sulfate

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
0409-1207
Requested NDC
0409-1207-13
Package NDCs from labels
0409-1207-13, 0409-1207-03, 0409-1207-15, 0409-1207-25
Manufacturer
Hospira, Inc.
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin SulfateHospira, Inc.2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-08HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate Injection, USP 80mg/2ml (40 mg/mL as Gentamicin)Henry Schein, Inc.2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2025-05-15HUMAN PRESCRIPTION DRUG LABEL
GENTAMICIN SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-27HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-03HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Hospira, Inc. | Lek d.d.Hospira, Inc. | Lek d.d.2022-11-17HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2021-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1207-03Gentamicin Sulfate25 in 1 TRAYINJECTION, SOLUTION2522
0409-1207-13Gentamicin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1207GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20241218_977180b3-a222-4282-d485-4a3217674305.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1207-03ML - Milliliter0409-1207b5d0f1ef-7c73-4fea-b4c9-9da361f7442412012-07-24
0409-1207-13ML - Milliliter0409-1207878db672-5c41-42ef-bba3-a1c57bc826c712018-02-20
0409-1207-15ML - Milliliter0409-12075582700a-cbe2-45e1-aec9-99f5c34a7dca12019-04-11
0409-1207-25ML - Milliliter0409-12073e0f5a91-ba57-48c1-9414-b94a3427b02d12016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
NITROGENINACTIVE INGREDIENTN762921K75GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]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 2 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BM BM115 DROPSBORAX, CAPSICUM, CONDURANGO, HYDRASTIS CAN, KALI PERM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBM Private Limited532302ff-e18c-de15-e063-6394a90a2b1c2026-05-31WarningsExact identifier
unii: O40UQP6WCF
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062420
ndc (package): 0409-1207-03
ndc (package): 0409-1207-13
ndc (product): 0409-1207
ndc11 (package): 00409120713
rxcui: 1870650
spl id: 317c0976-12f8-4263-bcb5-66583d1a1cae
spl set id: 977180b3-a222-4282-d485-4a3217674305
unii: 8X7386QRLV
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062420
ndc (package): 55154-2392-5
ndc (product): 55154-2392
rxcui: 1870650
spl id: 77f135ab-2291-487d-a9e2-50818624fa1a
spl set id: 5113bfad-42ca-4bb8-9343-0b08c6cd03f0
unii: 8X7386QRLV
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.53f4232b-23d4-48dc-aa76-175fdebfc74f2026-05-06WarningsExact identifier
unii: O40UQP6WCF
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: O40UQP6WCF
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Menopause ReliefAMYL NIT, CALC CARB, CAULOPHYLLUM, CIMICIFUGA, FERRUM MET, GELSEMIUM, LACHESIS, PULSATILLA, SANGUINARIA, SEPIA, SULPHUR AND SULPHURICUM AC.King Bio Inc.e12b75f5-6c5f-4b39-a6aa-dad07089f1d82026-03-10WarningsExact identifier
unii: O40UQP6WCF
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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