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 3 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: O40UQP6WCF
Lungs and Bronchial ReliefAMMONIUM CARBONICUM, ANTIMONIUM ARSENICICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BROMIUM, CARBO VEGETABILIS, CHLORINUM, KALI CARBONICUM, LOBELIA INFLATA, STANNUM METALLICUM, SULPHURICUM ACIDUM.King Bio Inc.fc4d4a56-3483-4cae-9818-fdae4e95ec6c2026-03-02WarningsExact identifier
unii: O40UQP6WCF
Mold PlusAGARICUS MUSCARIUS, ALLIUM CEPA, AMMONIUM CARBONICUM, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.372ad9cc-70eb-4f3f-b611-69e2d157c0582026-02-23WarningsExact identifier
unii: O40UQP6WCF
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Amikacin SulfateAMIKACIN SULFATEMullan Pharmaceutical Inc.840ba25a-d60c-4f0d-a084-71b0c68237df2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N6M33094FD
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: O40UQP6WCF
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: O40UQP6WCF
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: O40UQP6WCF
Large Joint Pain Drops 2037LARGE JOINT PAIN DROPSProfessional Complementary Health Formulasb34b0fce-9b7a-4f64-b557-b9c0ad61187c2026-01-08WarningsExact identifier
unii: O40UQP6WCF
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: O40UQP6WCF
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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