ACETAMINOPHEN ASPIRIN AND CAFFEINE

Product NDC
58602-883
11-digit product format
586020883
Labeler code
58602
Product ID
58602-883_6b949f81-2c9b-455b-9c0b-a497184d0fa4
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA211695
Marketing category
ANDA
Marketing start
2022-08-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58602-883-3458602088334200 TABLET, FILM COATED in 1 BOTTLE (58602-883-34) 2022-08-300000-00-00NoNoCurrent
58602-883-3858602088338300 TABLET, FILM COATED in 1 BOTTLE (58602-883-38) 2022-08-300000-00-00NoNoCurrent