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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U26EO4675QCAFFEINE CITRATE69-22-7CAFFEINE CITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6267-100064162671010 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01) 10 vial2024-01-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Caffeine Citrate Injection, USPHikma Pharmaceuticals USA Inc.2024-04-08HUMAN PRESCRIPTION DRUG LABEL12