butalbital, acetaminophen and caffeine
Approved
Approval ID
11690b28-5509-496a-9648-349158770ec2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2011
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
butalbital, acetaminophen and caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50436-4856
Application NumberANDA089175
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital, acetaminophen and caffeine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2011
FDA Product Classification
INGREDIENTS (10)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT