FDA.reportPublic FDA data

caffeine citrate

Product NDC
51754-0501
11-digit product format
517540501
Labeler code
51754
Product ID
51754-0501_6717d816-ee3c-4633-ba00-98e539734243
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
Substance
CAFFEINE CITRATE
Active strength
20 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
caffeine citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE CITRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU26EO4675Q
Rxcui849928

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-0501-2caffeine citrate5 in 1 CARTONSOLUTION53
51754-0501-2caffeine citrate3 mL in 1 VIALSOLUTION33
51754-0501-3caffeine citrate3 mL in 1 VIALSOLUTION33
51754-0501-3caffeine citrate10 in 1 CARTONSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0501-3ML - Milliliter51754-050102c09e94-fa84-4e49-9daf-f2c5a184466212015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Caffeine CitrateACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [EXELA PHARMA SCIENCES, LLC]2
CaffeineACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [EXELA PHARMA SCIENCES, LLC]2
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [EXELA PHARMA SCIENCES, LLC]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [EXELA PHARMA SCIENCES, LLC]2
WaterINACTIVE INGREDIENT059QF0KO0RCAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [EXELA PHARMA SCIENCES, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0501CAFFEINE CITRATE SOLUTION [EXELA PHARMA SCIENCES, LLC]3Current NDC, Legacy NDC, 4 package rows20200103_5d05ebf4-fd27-3bd1-5634-b41e33abc41f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSN5d05ebf4-fd27-3bd1-5634-b41e33abc41f3
849928caffeine citrate 20 MG/ML Oral SolutionSCD5d05ebf4-fd27-3bd1-5634-b41e33abc41f3
849928caffeine citrate 60 MG per 3 ML Oral SolutionSY5d05ebf4-fd27-3bd1-5634-b41e33abc41f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-0501-2517540501025 VIAL in 1 CARTON (51754-0501-2) / 3 mL in 1 VIAL5 vial2019-08-310000-00-00NoNoCurrent
51754-0501-35175405010310 VIAL in 1 CARTON (51754-0501-3) / 3 mL in 1 VIAL10 vial2015-03-300000-00-00NoNoCurrent