TRAMADOL HYDROCHLORIDE

Product NDC
50436-0698
11-digit product format
504360698
Labeler code
50436
Product ID
50436-0698_c156f766-a539-4db6-8c12-aea5057e6ad1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9N7R477WCKTRAMADOL HYDROCHLORIDE36282-47-0TRAMADOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0698-15043606980130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50436-0698-1) 2021-11-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRAMADOL HYDROCHLORIDEUnit Dose Services2021-11-05HUMAN PRESCRIPTION DRUG LABEL2