FDA.reportPublic FDA data

NDC 47335-290-40 - 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
47335-290
Requested NDC
47335-290-40
Package NDCs from labels
47335-290-40, 47335-290-44, 47335-290-26, 47335-290-27
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
47335-290-40Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSESOLUTION38
47335-290-44Caffeine Citrate10 in 1 CONTAINERSOLUTION108
47335-290-26Caffeine Citrate3 mL in 1 VIAL, SINGLE-DOSESOLUTION34
47335-290-27Caffeine Citrate10 in 1 CONTAINERSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-290CAFFEINE CITRATE INJECTION CAFFEINE CITRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 2 package rows20210301_cc632825-e0a4-4524-8d7d-ce926efab3d6.zip
47335-290CAFFEINE 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
47335-290-26ML - Milliliter47335-290dddb98c9-6e38-4af5-bf30-ea444084bf8512014-10-03
47335-290-27ML - Milliliter47335-2900b17f28b-2be6-49a4-ab7d-7774eb62679012014-10-03
47335-290-40ML - Milliliter47335-2905077a984-33e9-408d-9907-50d8a6b33d4e12021-07-15
47335-290-44ML - Milliliter47335-290a1766a18-4ddc-48ed-9e12-c9f8fec520ba12012-07-24

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 4 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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