FDA.reportPublic FDA data

NDC 0703-9040-01 - Amikacin 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
0703-9040
Requested NDC
0703-9040-01
Package NDCs from labels
0703-9040-01, 0703-9040-03
Manufacturer
Teva Parenteral Medicines, Inc.
Effective date
2022-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amikacin Sulfate Injection USPTeva Parenteral Medicines, Inc.2022-10-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-9040-01ML - Milliliter0703-9040e9d7c748-76ad-4fbc-a7a7-e556918a60c812012-07-24
0703-9040-03ML - Milliliter0703-9040a1a27f10-f0fb-4e01-b0f1-93afbcb468b912012-07-24
0703-9040-91ML - Milliliter0703-9040d58290ae-a8f2-450f-9332-43b8f68564ab12016-11-08
0703-9040-93ML - Milliliter0703-904034bb5ba8-4636-406f-82fb-1a09a8fa692012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIKACIN SULFATEACTIVE INGREDIENTN6M33094FDAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
AMIKACINACTIVE MOIETY84319SGC3CAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RAMIKACIN SULFATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]8

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 10 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulphuricum acidumSULFURIC ACIDBoiron86922572-6e29-fff4-e053-2991aa0abbd02023-11-15Exact identifier
unii: O40UQP6WCF
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, URANIUM NITRICUM, OZONEDeseret Biologicals, Inc.14a1f0a6-1b22-449c-b4dd-f8feb72155542023-10-26WarningsExact identifier
unii: O40UQP6WCF
Enviro Detox FormulaLAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SPINACIA, PETROLEUM, PLUMBUM METALLICUM, SULPHURICUM ACIDUM, AMMONIUM PHOSPHORICUM, ARSENICUM ALBUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, DIBROMOETHANE, KREOSOTUM, MERCURIUS VIVUS, MTBE (TERT-BUTYL METHYL ETHER), NITRICUM ACIDUM, RADIUM BROMATUMNutritional Specialties, Inc.83825312-dff8-4caa-8afa-bb1eab7397f72023-10-06WarningsExact identifier
unii: O40UQP6WCF
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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