Acetaminophen and Codeine Phosphate

Product NDC
68788-9229
11-digit product format
687889229
Labeler code
68788
Product ID
68788-9229_9c2944d5-8a1a-4472-9d42-75de599b2ec2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202800
Marketing category
ANDA
Marketing start
2014-10-16
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9229-16878892290115 TABLET in 1 BOTTLE (68788-9229-1) 15 tablet2014-10-160000-00-00NoNoCurrent
68788-9229-26878892290220 TABLET in 1 BOTTLE (68788-9229-2) 20 tablet2014-10-160000-00-00NoNoCurrent
68788-9229-36878892290330 TABLET in 1 BOTTLE (68788-9229-3) 30 tablet2014-10-160000-00-00NoNoCurrent
68788-9229-66878892290660 TABLET in 1 BOTTLE (68788-9229-6) 60 tablet2014-10-160000-00-00NoNoCurrent
68788-9229-96878892290990 TABLET in 1 BOTTLE (68788-9229-9) 90 tablet2014-10-160000-00-00NoNoCurrent