Acetaminophen and Codeine Phosphate

Product NDC
68084-372
11-digit product format
680840372
Labeler code
68084
Product ID
68084-372_c47dfb24-3e15-3080-e053-2a95a90ab2b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA089805
Marketing category
ANDA
Marketing start
2009-08-25
Marketing end
2022-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-372-0168084037201100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-372-01) > 1 TABLET in 1 BLISTER PACK (68084-372-11) 100 blister pack2009-08-250000-00-00NoNoCurrent