NDC 63323-013-01 - Thiamine

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
63323-013
Requested NDC
63323-013-01
Package NDCs from labels
63323-013-21, 63323-013-09, 63323-013-01, 63323-013-02, 63323-013-41, 63323-013-26
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Thiamine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-14HUMAN PRESCRIPTION DRUG LABEL
Thiamine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-13HUMAN PRESCRIPTION DRUG LABEL
Thiamine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-09HUMAN PRESCRIPTION DRUG LABEL
THIAMINE HCl - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-29HUMAN PRESCRIPTION DRUG LABEL
Thiamine - A-S Medication SolutionsA-S Medication Solutions2020-07-13HUMAN PRESCRIPTION DRUG LABEL
Thiamine HCL 100 mg/mL Injection, USP 2 mL Multi Dose VialPhysicians Total Care, Inc.2010-09-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-013-01Thiamine2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26
63323-013-02Thiamine25 in 1 TRAYINJECTION, SOLUTION256
63323-013-09Thiamine25 in 1 TRAYINJECTION, SOLUTION255
63323-013-21Thiamine2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION25
63323-013-26Thiamine25 in 1 TRAYINJECTION, SOLUTION253
63323-013-41Thiamine2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-013THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20241017_ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb.zip
63323-013THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241017_c3c9db74-95d4-487c-90c3-c810786fbaec.zip
63323-013THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 2 package rows20200527_af3f9344-f743-4bad-b319-53b96e13fee2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-013-01ML - Milliliter63323-01349732bda-dfb5-4e67-998c-fd732cbd90fe12020-07-13
63323-013-02ML - Milliliter63323-013131ed05c-1116-4369-b81d-52d41ba9910212013-02-13
63323-013-09ML - Milliliter63323-0138a6de6f4-eec9-4805-955c-d83920a7167d12014-05-02
63323-013-21ML - Milliliter63323-0135ed95b2f-910f-43e9-a02f-b09917676a6912020-07-13
63323-013-41ML - Milliliter63323-0137f2067f9-48bf-4dc0-940b-a21fd8b26d3c12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THIAMINE HYDROCHLORIDEACTIVE INGREDIENTM572600E5PTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
THIAMINE IONACTIVE MOIETY4ABT0J945JTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
Thiamine HydrochlorideACTIVE INGREDIENTM572600E5PTHIAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
THIAMINE HYDROCHLORIDEACTIVE INGREDIENTM572600E5PTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ThiamineACTIVE MOIETYX66NSO3N35THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
THIAMINE IONACTIVE MOIETY4ABT0J945JTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJTHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITHIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThiamineTHIAMINE HYDROCHLORIDECaplin Steriles Limited8909424c-9d5b-4e35-b2d3-da9d3316a4cc2024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: M572600E5P
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.63f3631b-ba1e-430c-a30b-dd05b2c00c132024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
Bio Cytotox PhasePODOPHYLLUM PELTATUM, ASCORBICUM ACIDUM, GALIUM APARINE, HYDRASTIS CANADENSIS, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, NATRUM OXALACETICUM, SULPHUR, VACCINIUM MYRTILLUS, NOREPINEPHRINE, ACETYLSALICYLICUM ACIDUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ANTHRACHINONUM, HISTAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NADIDUM, NAPHTHOCHINONUM, PANTOTHENIC ACID, UBIDECARENONUM,Deseret Biologicals, Inc.ca632470-6cbc-4994-a7f0-95b6ad9aa44f2024-03-14WarningsExact identifier
unii: M572600E5P
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
unii: M572600E5P
THIAMINE HClTHIAMINE HCLHF Acquisition Co LLC, DBA HealthFirstc4c436ab-cbb7-9429-e053-2995a90a58ae2024-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA080556
ndc (package): 51662-1523-1
ndc (package): 51662-1523-2
ndc (package): 51662-1523-3
ndc (product): 51662-1523
rxcui: 313324
spl id: 101e59b2-b8c3-3079-e063-6294a90a0a80
spl set id: c4c436ab-cbb7-9429-e053-2995a90a58ae
unii: M572600E5P
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: M572600E5P
TriStart DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENTCarWin Pharmaceutical Associates, LLC92ccf7d4-4527-49f0-b890-1a11b5a100862024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M572600E5P
Cellular OxygenatorCACTUS GRANDIFLORUS, ASCORBICUM ACIDUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, THIAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, RIBOFLAVINUM, MAGNESIA PHOSPHORICA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, ANTHRACHINONUM, COENZYME A, NADIDUM, NAJA TRIPUDIANS, UBIDECARENONUM (COQ10)Nutritional Specialties, Inc.e5869f25-276f-456a-ab05-2a1899845afb2023-11-21WarningsExact identifier
unii: M572600E5P
B Complex LiquescenceCHOLINUM (CHOLINE), INOSITOL (VITAMIN B8), FOLIC ACID (VITAMIN B9), PANTOTHENIC ACID (CALCIUM PANTOTHENATE, VITAMIN B5), THIAMINUM HYDROCHLORICUM (VITAMIN B1), HEART (BOVINE), HEPAR (BOVINE), METHYLCOBALAMIN (VITAMIN B12), NICOTINAMIDUM (VITAMIN B3), PABA (PARA AMINOBENZOIC ACID VITAMIN B10), PYRIDOXINUM HYDROCHLORICUM (VITAMIN B6), BIOTIN (VITAMIN B7), HORDEUM VULGARE, RIBOFLAVINUM (VITAMIN B2), TORULA CEREVISIAENutritional Specialties, Inc.a7382d84-1d5f-4d09-962f-b26f265af65e2023-10-09WarningsExact identifier
unii: M572600E5P
ThiamineTHIAMINE HYDROCHLORIDEArmas Pharmaceuticals Inc.9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd92023-05-22Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
ThiamineTHIAMINE HYDROCHLORIDENorthStar Rx LLCf4790075-a740-4550-9d4c-69a00dac354c2023-04-20Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: M572600E5P
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.43926cec-e483-8cf1-4d8d-5145e554d45d2022-12-30Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), PHLORIDZINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, BARYTA OXALICA, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS,Deseret Biologicals, Inc.5117f980-95b8-4fc8-9425-8f6f056394372022-12-29WarningsExact identifier
unii: M572600E5P
Bio Co-Enzyme PhaseBETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: M572600E5P
Vitamin B ComplexTHIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDEMylan Institutional LLC282ccec8-9bcd-4571-9b91-bbb96ef2620d2021-09-15Warnings, Adverse reactionsExact identifier
unii: M572600E5P
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEMylan Institutional LLC12986d0e-b8bf-4338-9d85-07f973b354392021-04-15Warnings, Adverse reactionsExact identifier
rxcui: 313324
unii: M572600E5P
e13f0b60-4212-4402-9b33-fdb28b51d5691a8ee45b-784c-4b90-aae2-f88d43ab771b2020-07-13Warnings, Adverse reactionsExact identifier
spl id: e13f0b60-4212-4402-9b33-fdb28b51d569
spl set id: 1a8ee45b-784c-4b90-aae2-f88d43ab771b
ESSENTIAL WEIGHT LOSSAMMONIUM BROMATUM, FUCUS VESICULOSUS, NATRUM SULPHURICUM, NICOTINAMIDUM, SPONGIA TOSTA, THIAMINUM HYDROCHLORICUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THYROIDINUM (BOVINE), CALCAREA CARBONICA, GRAPHITESIntegrative Health Alliance4f114242-fbe0-4f23-bbe7-c74fa2d091aa2019-11-11WarningsExact identifier
unii: M572600E5P

Reported adverse events (FAERS/openFDA)#

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