NDC 50383-337

Acetaminophen and Codeine Phosphate

Acetaminophen And Codeine Phosphate

Acetaminophen and Codeine Phosphate is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Acetaminophen; Codeine Phosphate.

Product ID50383-337_44f939cd-f7f6-4406-b8f4-902a1443534f
NDC50383-337
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen and Codeine Phosphate
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1996-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA040119
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Active Ingredient Strength120 mg/5mL; mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50383-337-06

4 TRAY in 1 CASE (50383-337-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-337-05)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-337-05 [50383033705]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-04-26

NDC 50383-337-06 [50383033706]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN120 mg/5mL

Pharmacological Class

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

NDC Crossover Matching brand name "Acetaminophen and Codeine Phosphate" or generic name "Acetaminophen And Codeine Phosphate"

NDCBrand NameGeneric Name
0093-0050Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
0093-0150Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
0121-0504Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATE
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphate
68071-3100Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-3061Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-3272Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-4475ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
68071-4430ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-4668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-4749Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68071-4533ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
68084-372Acetaminophen And Codeine PhosphateAcetaminophen And Codeine Phosphate
68084-373Acetaminophen And Codeine PhosphateAcetaminophen And Codeine Phosphate
68788-0076Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68788-0285Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68788-9300Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
68788-9506ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
68788-9736Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
70518-1592Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
71335-0256Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
71205-001Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
71335-0701Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
71335-0336Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
71610-111ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
0615-7792Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
0615-8102Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
10544-032ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
12634-975Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
12634-526ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
17856-0079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
21695-243ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
21695-242ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
21695-547Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
33261-470Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
42254-145Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
42254-022Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphate
45865-439Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
45865-466Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.