NDC 71309-996 - Amikacin Sulfate Injection, 500 mg/2ml

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
71309-996
Package NDCs from labels
71309-996-05
Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2021-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amikacin Sulfate Injection, 500 mg / 2mlSafrel Pharmaceuticals, LLC.2021-01-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-996-052023-01-30C16284748780-1f386c649-dafa-0266-e053-dadaa90a7c1aAmikacin Sulfate Injection, 500 mg / 2ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-996-05Amikacin Sulfate Injection, 500 mg/2ml500 in 1 VIALINJECTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-996AMIKACIN SULFATE INJECTION, 500 MG/2ML INJECTION [SAFREL PHARMACEUTICALS, LLC.]11 package rows20210107_b834ed2b-d0c5-6db3-e053-2995a90aa963.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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Injure GelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUMNatural Creations, Inc8893c906-0dab-44ef-956b-b5427d4dbf7f2018-12-21WarningsExact identifier
unii: O40UQP6WCF
Hangover ReliefASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC.Homeocare Laboratories93b4a184-572c-48ef-9fc0-8e357a1e0d1b2018-12-18WarningsExact identifier
unii: O40UQP6WCF
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
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.6da04ff9-4088-427c-9757-36092c8f75852018-02-08WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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