Acetaminophen and Codeine Phosphate

Product NDC
60687-615
11-digit product format
606870615
Labeler code
60687
Product ID
60687-615_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
2021-12-13
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
60687-615-01EA - Each60687-6159917b433-1a9b-4bbf-9f83-d7bf03fd847c12021-10-08
60687-615-11EA - Each60687-615548852c6-9dad-4062-9aa7-948b5331d76912021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-615-0160687061501100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-615-01) > 1 TABLET in 1 BLISTER PACK (60687-615-11) 100 blister pack2021-09-010000-00-00NoNoCurrent