FDA.reportPublic FDA data

NDC 0517-1045-01 - Levocarnitine

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
0517-1045
Requested NDC
0517-1045-01
Package NDCs from labels
0517-1045-01, 0517-1045-05
Manufacturer
American Regent, Inc.
Effective date
2023-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levocarnitine - American Regent, Inc.American Regent, Inc.2023-06-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-1045-01Levocarnitine5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION511
0517-1045-05Levocarnitine5 in 1 CARTONINJECTION, SOLUTION511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-1045LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]11Current NDC, Legacy NDC, 2 package rows20240123_cc4da2c3-f939-444d-9b5b-a57b6051c190.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1045-01ML - Milliliter0517-10454beb0e51-8500-4393-bcd0-4d295296219a12023-08-08
0517-1045-05ML - Milliliter0517-1045ecefb220-f549-4858-9d72-088e79d1aea212023-08-08
0517-1045-25ML - Milliliter0517-104530ec5e83-e0b2-48b1-8898-c119b8245cf412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOCARNITINEACTIVE INGREDIENT0G389FZZ9MLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
LEVOCARNITINEACTIVE MOIETY0G389FZZ9MLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4

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 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Strength FALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS)BioActive Nutritional, Inc.a4f3a8e7-0a28-4aa0-ba0c-201807d62c962025-01-03WarningsExact identifier
unii: 0G389FZZ9M
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
LevocarnitineLEVOCARNITINETRUPHARMA, LLC05ab18c1-fb01-48fa-8f05-0200bb8a5edf2024-12-27Warnings, Adverse reactionsExact identifier
unii: 0G389FZZ9M
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Carnitor SFLEVOCARNITINELeadiant Biosciences, Inc.dd904490-83f3-4cd3-bb6f-68e28509b4b62024-11-04Warnings, Adverse reactionsExact identifier
unii: 0G389FZZ9M
CARNITORLEVOCARNITINELeadiant Biosciences, Inc.d2133bc3-9c15-48bd-8b16-b8995a6a14cd2024-10-30Warnings, Adverse reactionsExact identifier
unii: 0G389FZZ9M
Cardio TonicCACTUS GRANDIFLORUS, L-CARNITINE, LINUM USITATISSIMUM, STROPHANTHUS HISPIDUS, BORAGO OFFICINALIS, HEART (SUIS), KALI CARBONICUM, KALI NITRICUM, THYROIDINUM (SUIS), ADONIS VERNALIS, DIGITALIS PURPUREA, LYCOPUS VIRGINICUSEnergique, Inc.3b69f1ff-ecfc-48ca-86d8-7130f32cb7722024-10-24WarningsExact identifier
unii: 0G389FZZ9M
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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