TRAMADOL HYDROCHLORIDE

Product NDC
55700-016
11-digit product format
557000016
Labeler code
55700
Product ID
55700-016_f8e478fd-612d-4d25-a349-48c3fb48e291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
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
55700-016-305570000163030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-016-30) 2011-12-120000-00-00NoNoCurrent