caffeine citrate

Product NDC
51754-0503
11-digit product format
517540503
Labeler code
51754
Product ID
51754-0503_74eacede-e465-482b-979f-773b4d531764
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAFFEINE CITRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Exela Pharma Sciences, LLC
Application
ANDA077304
Marketing category
ANDA
Marketing start
2006-09-21
Marketing end
0000-00-00
Substance
CAFFEINE CITRATE
Active strength
20 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0503-3ML - Milliliter51754-0503148e6b11-a1bc-41a1-baa6-850dd7c8830012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0503CAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]2Legacy NDC20210318_bd6ac18d-c65c-42bc-a3ca-7a428c13aae7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-0503-35175405030310 VIAL, SINGLE-DOSE in 1 CONTAINER (51754-0503-3) > 3 mL in 1 VIAL, SINGLE-DOSE2006-09-210000-00-00NoNoCurrent