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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Amikacin SulfateAMIKACIN SULFATEFresenius Kabi USA, LLCc0f57839-1c9b-49e5-8c7a-708e2d16495d2023-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N6M33094FD
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
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: O40UQP6WCF
SEPIA PLEXACONITUM NAPELLUS, CIMICIFUGA RACEMOSA, LACHESIS MUTUS, MELISSA OFFICINALIS, PLATINUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA, SULPHURICUM ACIDUM, VALERIANA OFFICINALISSeroyal USA4c4a0a95-3848-4e19-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: O40UQP6WCF
Visceral PolarityACONITUM NAP, ARG NIT, CHININUM PUR, ECHINACEA PURP, PLUM MET, SEPIA, SULPHURICUM ACNET Remedies971e74ea-f72f-403e-bc79-02901e5019e82021-01-21WarningsExact identifier
unii: O40UQP6WCF
b834ed2b-d0c6-6db3-e053-2995a90aa963b834ed2b-d0c5-6db3-e053-2995a90aa9632021-01-03Exact identifier
spl id: b834ed2b-d0c6-6db3-e053-2995a90aa963
spl set id: b834ed2b-d0c5-6db3-e053-2995a90aa963
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: O40UQP6WCF
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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