caffeine citrate

Product NDC
51754-0502
11-digit product format
517540502
Labeler code
51754
Product ID
51754-0502_d93dd760-6b92-4b1b-9fd6-960c3c25f3ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAFFEINE CITRATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
ANDA077233
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
51754-0502-1ML - Milliliter51754-05023a18034a-d6a6-4263-a0ff-2b616e0b8add12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0502CAFFEINE CITRATE INJECTION [EXELA PHARMA SCIENCES, LLC]2Legacy NDC20210318_6de25a89-23b3-41e3-91aa-d86ca83686d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-0502-35175405020310 VIAL, SINGLE-DOSE in 1 CARTON (51754-0502-3) > 3 mL in 1 VIAL, SINGLE-DOSE (51754-0502-1) 2006-09-210000-00-00NoNoCurrent