FDA.reportPublic FDA data

Caffeine Citrate

Product NDC
0641-6267
11-digit product format
006416267
Labeler code
0641
Product ID
0641-6267_a6bcf6c4-f765-4334-9743-c5db0546d903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
caffeine citrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA020793
Marketing category
NDA
Marketing start
2024-01-11
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0641-6267-01Caffeine Citrate3 mL in 1 VIALINJECTION312
0641-6267-10Caffeine Citrate10 in 1 BOXINJECTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6267-01ML - Milliliter0641-6267389a3baf-0226-48f9-a386-31f249c4a38b12024-07-12
0641-6267-10ML - Milliliter0641-62678aba8a1a-1e2b-40dc-8cd0-ba2e6a3c217212024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINE CITRATEACTIVE INGREDIENTU26EO4675QCAFCIT (CAFFEINE CITRATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
CAFFEINEACTIVE MOIETY3G6A5W338ECAFCIT (CAFFEINE CITRATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAFCIT (CAFFEINE CITRATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCAFCIT (CAFFEINE CITRATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFCIT (CAFFEINE CITRATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6267CAFFEINE CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, 2 package rows20240410_21489401-f2a7-47d3-897a-4b7efa04dd7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849931caffeine citrate 60 MG in 3 ML InjectionPSN21489401-f2a7-47d3-897a-4b7efa04dd7a12
8499313 ML caffeine citrate 20 MG/ML InjectionSCD21489401-f2a7-47d3-897a-4b7efa04dd7a12
849931caffeine citrate 20 MG/ML (caffeine base 10 MG/ML) InjectionSY21489401-f2a7-47d3-897a-4b7efa04dd7a12
849931caffeine citrate 60 MG per 3 ML InjectionSY21489401-f2a7-47d3-897a-4b7efa04dd7a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6267-01006416267013 mL in 1 VIAL3 mlHistorical
0641-6267-100064162671010 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01) 10 vial2024-01-11NoNoCurrent