FDA.reportPublic FDA data

caffeine citrate

Product NDC
51754-0500
11-digit product format
517540500
Labeler code
51754
Product ID
51754-0500_0408e50a-e029-40d6-9ccf-2399edbcddf9
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
2015-03-30
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
Rxcui849931

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
51754-0500-1caffeine citrate3 mL in 1 VIALINJECTION32
51754-0500-1caffeine citrate1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0500-1ML - Milliliter51754-050013fbe5f1-c535-4895-85dc-92bb0b51a8b412015-05-05

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
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCAFFEINE 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
51754-0500CAFFEINE CITRATE INJECTION [EXELA PHARMA SCIENCES, LLC]2Current NDC, Legacy NDC, 2 package rows20200123_f423a220-e7bf-4d24-bc52-bafc1864265b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSNf423a220-e7bf-4d24-bc52-bafc1864265b2
8499313 ML caffeine citrate 20 MG/ML InjectionSCDf423a220-e7bf-4d24-bc52-bafc1864265b2
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSYf423a220-e7bf-4d24-bc52-bafc1864265b2
849931caffeine citrate 60 MG per 3 ML InjectionSYf423a220-e7bf-4d24-bc52-bafc1864265b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-0500-1517540500011 VIAL in 1 CARTON (51754-0500-1) / 3 mL in 1 VIAL1 vial2015-03-300000-00-00NoNoCurrent