Acetaminophen and Codeine Phosphate

Product NDC
60687-604
11-digit product format
606870604
Labeler code
60687
Product ID
60687-604_eb8db7a6-074e-30db-e053-2a95a90a3a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA202800
Marketing category
ANDA
Marketing start
2021-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-604-01EA - Each60687-6041de1185a-07a3-4ca0-aac1-d052374f382112021-10-08
60687-604-11EA - Each60687-60465890d0a-2a43-4f56-98d6-3a264c205df012021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-604-0160687060401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-604-01) > 1 TABLET in 1 BLISTER PACK (60687-604-11) 100 blister pack2021-09-010000-00-00NoNoCurrent