Tramadol Hydrochloride and Acetaminophen

Product NDC
42291-832
11-digit product format
422910832
Labeler code
42291
Product ID
42291-832_9c9504a4-c68d-362b-e053-2a95a90a5715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA090485
Marketing category
ANDA
Marketing start
2015-03-27
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-832-904229108329090 TABLET in 1 BOTTLE (42291-832-90) 90 tablet2015-03-270000-00-00NoNoCurrent