TRAMADOL HYDROCHLORIDE

Product NDC
50090-5107
11-digit product format
500905107
Labeler code
50090
Product ID
50090-5107_b7fc852d-2c89-430e-81d2-c61614d4ccd7
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
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5107-05009051070030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5107-0) 2020-07-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRAMADOL HYDROCHLORIDEA-S Medication Solutions2025-09-05HUMAN PRESCRIPTION DRUG LABEL8
TRAMADOL HYDROCHLORIDEA-S Medication Solutions2024-06-03HUMAN PRESCRIPTION DRUG LABEL6