FDA.reportPublic FDA data

NDC 47335-289-26 - 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
47335-289
Requested NDC
47335-289-26
Package NDCs from labels
47335-289-40, 47335-289-26, 47335-289-27
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2020-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2020-12-12Human Prescription Drug Label
Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2019-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-289-40Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSEINJECTION38
47335-289-40Caffeine Citrate1 in 1 CARTONINJECTION18
47335-289-26Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSEINJECTION34
47335-289-27Caffeine Citrate1 in 1 CARTONINJECTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-289CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 2 package rows20210301_cc632825-e0a4-4524-8d7d-ce926efab3d6.zip
47335-289CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20190302_d06d3810-9923-4199-be5e-ee5ee086b0a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-289-26ML - Milliliter47335-289eb3350f5-a4ae-40ca-8187-02f662fa703812014-10-03
47335-289-27ML - Milliliter47335-2891e064022-0d4b-467b-8af6-10e21df6092b12014-10-03
47335-289-40ML - Milliliter47335-289598d42fd-0d41-42f1-8e6c-a190e1c890d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]3
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]3
WATERINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]3
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]1
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMA GLOBAL FZE]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 1 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CAFFEINE CITRATECAFFEINE CITRATEMicro Labs Limited279a43b8-9ff5-4792-ac19-441f3fa492692026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 849931
unii: U26EO4675Q
Caffeine CitrateCAFFEINE CITRATEMicro Labs Limiteddb4477a3-b291-4b77-9eca-b7ba8f66b2be2026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 849928
unii: U26EO4675Q
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
caffeine citrateCAFFEINE CITRATESagent Pharmaceuticals5f38c395-0093-4afd-89ec-f96e5dc0934a2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 849931
rxcui: 849928
unii: U26EO4675Q
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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