TRAMADOL HYDROCHLORIDE

Product NDC
68788-7762
11-digit product format
687887762
Labeler code
68788
Product ID
68788-7762_820477b9-3601-4aeb-b262-b30c01129c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA201384
Marketing category
ANDA
Marketing start
2020-07-22
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
68788-7762-26878877620220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-2) 2020-07-220000-00-00NoNoCurrent
68788-7762-36878877620330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-3) 2020-07-220000-00-00NoNoCurrent
68788-7762-66878877620660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-6) 2020-07-220000-00-00NoNoCurrent
68788-7762-96878877620990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-9) 2020-07-220000-00-00NoNoCurrent