TRAMADOL HYDROCHLORIDE

Product NDC
68071-5261
11-digit product format
680715261
Labeler code
68071
Product ID
68071-5261_d7724981-3caf-cb8f-e053-2a95a90af84f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
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
68071-5261-36807152610330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5261-3) 2020-05-220000-00-00NoNoCurrent