Acetaminophen and Codeine Phosphate

Product NDC
0615-8102
11-digit product format
006158102
Labeler code
0615
Product ID
0615-8102_eac0a4e4-a88f-476a-9394-1cde02f9647e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202800
Marketing category
ANDA
Marketing start
2017-01-05
Marketing end
2023-11-30
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
0615-8102-390061581023930 TABLET in 1 BLISTER PACK (0615-8102-39) 30 tablet2017-01-050000-00-00NoNoCurrent