FDA.reportPublic FDA data

NDC 63323-406-01 - Caffeine Citrate

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
63323-406
Requested NDC
63323-406-01
Package NDCs from labels
63323-406-01, 63323-406-03
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2019-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Caffeine Citrate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2019-02-28Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-406-01Caffeine Citrate3 mL in 1 VIALSOLUTION35
63323-406-03Caffeine Citrate5 in 1 CARTONSOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-406CAFFEINE CITRATE SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20190430_b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-406-01ML - Milliliter63323-4066e79cac3-2884-43a7-abd1-f7c5ff9df8ae12019-12-10
63323-406-03ML - Milliliter63323-406bb9de3ac-c8d4-4f98-9847-31b8ac985b9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3

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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Caffeine Citrate Oral SolutionCAFFEINE CITRATEArmas Pharmaceuticals Inc.2bd238d4-4657-4341-9c28-1b468b8f3bf82023-07-31Warnings, Adverse reactionsExact identifier
rxcui: 849928
unii: U26EO4675Q
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLCbaf9f88a-776a-44e7-82cc-8f0ca419572f2023-07-20Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
CAFFEINE CITRATECAFFEINE CITRATEArmas Pharmaceuticals Inc.c1129235-f7f6-43eb-8d6e-786c14c16f2f2023-07-18Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLC38b39044-737a-4247-a6c4-c86f5e92490e2023-07-14Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
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
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.cc632825-e0a4-4524-8d7d-ce926efab3d62020-12-12Warnings, Adverse reactionsExact identifier
rxcui: 849928
unii: U26EO4675Q
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
Caffeine CitrateCAFFEINE CITRATESun Pharmaceutical Industries, Inc.d06d3810-9923-4199-be5e-ee5ee086b0a42019-03-01Warnings, Adverse reactionsExact identifier
rxcui: 849928
unii: U26EO4675Q
Caffeine CitrateCAFFEINE CITRATEFresenius Kabi USA, LLCb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e2019-02-28Warnings, Adverse reactionsExact identifier
application number: ANDA078002
ndc (package): 63323-406-01
ndc (package): 63323-406-03
ndc (product): 63323-406
ndc11 (package): 63323040601
rxcui: 849928
spl id: 8d47943c-b6f3-4742-90fe-4667e19c8605
spl set id: b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e
unii: U26EO4675Q
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
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
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLCf423a220-e7bf-4d24-bc52-bafc1864265b2015-03-30Warnings, Adverse reactionsExact identifier
unii: U26EO4675Q
caffeine citrateCAFFEINE CITRATEExela Pharma Sciences, LLC5d05ebf4-fd27-3bd1-5634-b41e33abc41f2015-03-26Warnings, Adverse reactionsExact identifier
rxcui: 849928
unii: U26EO4675Q

Reported adverse events (FAERS/openFDA)#

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