TRAMADOL HYDROCHLORIDE

Product NDC
50090-5106
11-digit product format
500905106
Labeler code
50090
Product ID
50090-5106_de82c11b-bf19-473a-8e38-7b882a0936fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-5106-05009051060030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5106-0) 2020-07-170000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRAMADOL HYDROCHLORIDEA-S Medication Solutions2024-06-03HUMAN PRESCRIPTION DRUG LABEL6