FDA.reportPublic FDA data

Caffeine Citrate

Product NDC
63323-406
11-digit product format
633230406
Labeler code
63323
Product ID
63323-406_8d47943c-b6f3-4742-90fe-4667e19c8605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAFFEINE CITRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Fresenius Kabi USA, LLC
Application
ANDA078002
Marketing category
ANDA
Marketing start
2009-11-19
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
63323-406-01Caffeine Citrate3 mL in 1 VIALSOLUTION35
63323-406-03Caffeine Citrate5 in 1 CARTONSOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-406-01ML - Milliliter63323-4066e79cac3-2884-43a7-abd1-f7c5ff9df8ae12019-12-10
63323-406-03ML - Milliliter63323-406bb9de3ac-c8d4-4f98-9847-31b8ac985b9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCAFFEINE CITRATE SOLUTION [APP PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-406CAFFEINE CITRATE SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20190430_b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849928caffeine citrate 60 MG in 3 mL Oral SolutionPSNb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e5
849928caffeine citrate 20 MG/ML Oral SolutionSCDb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e5
849928caffeine citrate 60 MG per 3 ML Oral SolutionSYb4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-406-01633230406013 mL in 1 VIAL3 mlHistorical
63323-406-03633230406035 VIAL in 1 CARTON (63323-406-03) / 3 mL in 1 VIAL (63323-406-01) 5 vial2009-11-190000-00-00NoNoCurrent