Tramadol Hydrochloride and Acetaminophen

Product NDC
63629-3406
11-digit product format
636293406
Labeler code
63629
Product ID
63629-3406_34f0bb89-bf50-451d-bca5-aa07a44e751a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3406-06362934060028 TABLET in 1 BOTTLE (63629-3406-0) 28 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-16362934060120 TABLET in 1 BOTTLE (63629-3406-1) 20 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-26362934060260 TABLET in 1 BOTTLE (63629-3406-2) 60 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-36362934060350 TABLET in 1 BOTTLE (63629-3406-3) 50 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-46362934060430 TABLET in 1 BOTTLE (63629-3406-4) 30 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-56362934060540 TABLET in 1 BOTTLE (63629-3406-5) 40 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-66362934060690 TABLET in 1 BOTTLE (63629-3406-6) 90 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-763629340607120 TABLET in 1 BOTTLE (63629-3406-7) 120 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-863629340608100 TABLET in 1 BOTTLE (63629-3406-8) 100 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-96362934060945 TABLET in 1 BOTTLE (63629-3406-9) 45 tablet2009-12-170000-00-00NoNoCurrent