FDA.reportPublic FDA data

NDC 0143-9129-01 - 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
0143-9129
Requested NDC
0143-9129-01
Package NDCs from labels
0143-9129-01, 0143-9129-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2023-09-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2023-09-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9129-01Gentamicin20 mL in 1 VIALINJECTION, SOLUTION202
0143-9129-10Gentamicin10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9129GENTAMICIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20230908_51fffac8-fb6e-4f7f-b2de-440252781a42.zip

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 5 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GentamicinGENTAMICINHikma Pharmaceuticals USA Inc.51fffac8-fb6e-4f7f-b2de-440252781a422023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA062251
ndc (package): 0143-9129-10
ndc (package): 0143-9128-01
ndc (package): 0143-9129-01
ndc (package): 0143-9128-25
ndc (product): 0143-9128
ndc (product): 0143-9129
ndc11 (package): 00143912901
rxcui: 313996
spl id: 9908273d-c700-4036-82fe-312f25a8aacd
spl set id: 51fffac8-fb6e-4f7f-b2de-440252781a42
unii: 8X7386QRLV
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Acidum SulphuricumACIDUM SULPHURICUMHahnemann Laboratories, INC.038c2235-b113-963d-e063-6394a90a2b102023-08-22Exact identifier
unii: O40UQP6WCF
Fem Flora DefenseBAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.8015e1cb-9ebd-4b3e-af57-92f2754fb7902023-08-17WarningsExact identifier
unii: O40UQP6WCF
Clearlife Extra StrengthONION, AMBROSIA ARTEMISIIFOLIA WHOLE, APIS MELLIFERA, ARNICA MONTANA WHOLE, EUPHRASIA STRICTA, GRAPHITE,GALPHIMIA GLAUCA FLOWERING TOP,PULSATILLA VULGARIS WHOLE, HISTAMINE DIHYDROCHLORIDE, PINE TAR, SCHOENOCAULON OFFICINALE SEED, SULFUR, SULFURIC ACID,TELLURIUM AND THUJA OCCIDENTALIS LEAFY TWIGMediNatura Inc.088ba0ac-8ffa-4057-8286-88765c228f392023-06-05WarningsExact identifier
unii: O40UQP6WCF
Gentamicin SulfateGENTAMICIN SULFATEA-S Medication Solutions76fabcd6-4da3-49e3-85a1-ca4fac55a2072023-05-08Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLCa8b15217-cccb-2260-e053-2995a90a709d2023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltd4cfbe37e-11d6-46fc-b287-0561387b17b72023-01-31Adverse reactionsExact identifier
unii: 8X7386QRLV
PROSCENATSULFURIC ACID, LYTTA VESICATORIA, CONIUM MACULATUM FLOWERING TOP, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, NASTURTIUM OFFICINALE WHOLE, AND ONONIS SPINOSA WHOLEPEKANA Naturheilmittel GmbH1fe525a2-7ff6-4704-ab47-08552eb5ba4a2023-01-11WarningsExact identifier
unii: O40UQP6WCF
OPSONATSILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbH506f8227-207c-462c-a71c-5f8f00b4f8de2023-01-11WarningsExact identifier
unii: O40UQP6WCF
GLUCOREKTLACTIC ACID, DL-, SULFURIC ACID, ONION, CHIONANTHUS VIRGINICUS BARK, PHOSPHORUS, ZINC SULFATE HEPTAHYDRATE, CORN SILK, AND SYZYGIUM CUMINI FRUITPEKANA Naturheilmittel GmbH86293764-46a8-455a-8cba-7b4b3e1273872023-01-11WarningsExact identifier
unii: O40UQP6WCF
ChemDetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUMDr. Donna Restivo DC2a17f80d-12c0-43a0-980b-9da648e9b76a2023-01-10WarningsExact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8693236a-a8ab-2f7f-e053-2991aa0a11962023-01-05Exact identifier
unii: O40UQP6WCF
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: O40UQP6WCF
Bruise RXERIGERON CANADENSIS, HAMAMELIS VIRGINIANA, PHOSPHORUS, SULPHURICUM ACIDUM, ARNICA MONTANA, LEDUM PALUSTRE, BELLIS PERENNISRemedies Cure, LLC8fbac9c7-45ac-4a9b-bdff-6f19d238a6012022-08-10WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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