Acetaminophen and Codeine Phosphate

Product NDC
82804-181
11-digit product format
828040181
Labeler code
82804
Product ID
82804-181_5d9123f6-b322-4fa0-bf48-6335a6adcbb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA089805
Marketing category
ANDA
Marketing start
2024-05-20
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
GSL05Y1MN6CODEINE PHOSPHATE41444-62-6CODEINE PHOSPHATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-181-308280401813030 TABLET in 1 BOTTLE (82804-181-30) 30 tablet2025-01-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/30 mg) Rx OnlyProficient Rx LP2025-01-01HUMAN PRESCRIPTION DRUG LABEL1