Butalbital, Aspirin, Caffeine and Codeine Phosphate

Product NDC
0527-1312
11-digit product format
005271312
Labeler code
0527
Product ID
0527-1312_b040a6d6-8f3b-4f09-825f-cf2a2fec2499
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA074951
Marketing category
ANDA
Marketing start
1998-08-31
Marketing end
0000-00-00
Substance
BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
Active strength
50 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1312-01EA - Each0527-13125f701205-a83f-4f58-9467-987d9c0f1d2212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1312-0100527131201100 CAPSULE in 1 BOTTLE (0527-1312-01) 100 capsule1998-08-310000-00-00NoNoCurrent