TRAMADOL HYDROCHLORIDE

Product NDC
68071-2732
11-digit product format
680712732
Labeler code
68071
Product ID
68071-2732_dfd9ef7e-d3a0-96a9-e053-2a95a90a4cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2732-36807127320330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2732-3) 2022-05-250000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.2022-05-25HUMAN PRESCRIPTION DRUG LABEL1