NDC 12634-975

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 Apotheca Inc.. The primary component is Acetaminophen; Codeine Phosphate.

Product ID12634-975_29b417d1-cea5-49da-e054-00144ff88e88
NDC12634-975
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 NameApotheca 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 Through2019-12-31

Packaging

NDC 12634-975-06

180 mL in 1 BOTTLE (12634-975-06)
Marketing Start Date1996-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-975-04 [12634097504]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-04-26
Marketing End Date2016-01-26

NDC 12634-975-06 [12634097506]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-04-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN120 mg/5mL

OpenFDA Data

SPL SET ID:ccfaceb3-b3d3-4400-bae8-83e2ee272021
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993755
  • 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.