Tramadol HCL

Product NDC
80425-0101
11-digit product format
804250101
Labeler code
80425
Product ID
80425-0101_d102ce7b-fc38-0dd0-e053-2995a90a1767
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol HCL
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA200491
Marketing category
ANDA
Marketing start
2012-06-27
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0101-28042501010260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0101-2) 2012-06-270000-00-00NoNoCurrent