TRAMADOL HYDROCHLORIDE

Product NDC
68788-7763
11-digit product format
687887763
Labeler code
68788
Product ID
68788-7763_bbaa371a-1560-45aa-af2d-a6f910225357
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
100 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7763-26878877630220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7763-2) 2020-07-220000-00-00NoNoCurrent
68788-7763-36878877630330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7763-3) 2020-07-220000-00-00NoNoCurrent
68788-7763-66878877630660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7763-6) 2020-07-220000-00-00NoNoCurrent
68788-7763-96878877630990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7763-9) 2020-07-220000-00-00NoNoCurrent