TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
68788-7712
11-digit product format
687887712
Labeler code
68788
Product ID
68788-7712_a0121c84-0ee7-4006-b411-6d600206e66a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA201952
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7712-168788771201100 TABLET, FILM COATED in 1 BOTTLE (68788-7712-1) 2020-07-010000-00-00NoNoCurrent
68788-7712-26878877120220 TABLET, FILM COATED in 1 BOTTLE (68788-7712-2) 2020-07-010000-00-00NoNoCurrent
68788-7712-36878877120330 TABLET, FILM COATED in 1 BOTTLE (68788-7712-3) 2020-07-010000-00-00NoNoCurrent
68788-7712-46878877120440 TABLET, FILM COATED in 1 BOTTLE (68788-7712-4) 2020-07-010000-00-00NoNoCurrent
68788-7712-56878877120550 TABLET, FILM COATED in 1 BOTTLE (68788-7712-5) 2020-07-010000-00-00NoNoCurrent
68788-7712-66878877120660 TABLET, FILM COATED in 1 BOTTLE (68788-7712-6) 2020-07-010000-00-00NoNoCurrent
68788-7712-868788771208120 TABLET, FILM COATED in 1 BOTTLE (68788-7712-8) 2020-07-010000-00-00NoNoCurrent
68788-7712-96878877120990 TABLET, FILM COATED in 1 BOTTLE (68788-7712-9) 2020-07-010000-00-00NoNoCurrent