CAFFEINE CITRATE
Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USP
Approved
Approval ID
dfa7e0a9-eac0-4741-9b85-69c122f13e33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2009
Manufacturers
FDA
Sun Pharmaceutical Industries Ltd
DUNS: 650172430
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CAFFEINE CITRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-289
Application NumberANDA090077
Product Classification
M
Marketing Category
C73584
G
Generic Name
CAFFEINE CITRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 2, 2009
FDA Product Classification
INGREDIENTS (4)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAFFEINE CITRATEActive
Quantity: 20 mg in 1 mL
Code: U26EO4675Q
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CAFFEINE CITRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-290
Application NumberANDA090357
Product Classification
M
Marketing Category
C73584
G
Generic Name
CAFFEINE CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2009
FDA Product Classification
INGREDIENTS (4)
CAFFEINE CITRATEActive
Quantity: 20 mg in 1 mL
Code: U26EO4675Q
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT