Basic Information
Butalbital, Acetaminophen and Caffeine
13107-075
Regulatory Information
13107-075
ANDA204733
C73584
September 10, 2019
USA
Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
Human Prescription Drug Label
2
Company Information
829084461
Active Ingredients
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
CROSPOVIDONE
Code: 68401960MK
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
Active Moieties
BUTALBITAL
Code: KHS0AZ4JVK
ACETAMINOPHEN
Code: 362O9ITL9D
CAFFEINE
Code: 3G6A5W338E