NDC 50383-079

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 ID50383-079_44f939cd-f7f6-4406-b8f4-902a1443534f
NDC50383-079
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 50383-079-16

473 mL in 1 BOTTLE (50383-079-16)
Marketing Start Date1996-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-079-16 [50383007916]

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

NDC 50383-079-15 [50383007915]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-18
Marketing End Date2020-02-06

NDC 50383-079-12 [50383007912]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-18
Marketing End Date2020-02-06

NDC 50383-079-05 [50383007905]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-18
Marketing End Date2020-02-06

NDC 50383-079-10 [50383007910]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-18
Marketing End Date2020-02-06

NDC 50383-079-13 [50383007913]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-17
Marketing End Date2020-02-06

NDC 50383-079-06 [50383007906]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-17
Marketing End Date2020-02-06

NDC 50383-079-17 [50383007917]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-17
Marketing End Date2020-02-06

NDC 50383-079-11 [50383007911]

Acetaminophen and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040119
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-17
Marketing End Date2020-02-06

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN120 mg/5mL

OpenFDA Data

SPL SET ID:83a536d8-385d-46ed-9cd2-47b7efe96ccf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993755

    • Pharmacological Class

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

    Medicade Reported Pricing

    50383079616 HYDROXYZINE 10 MG/5 ML SOLN

    Pricing Unit: ML | Drug Type:

    50383079516 LACTULOSE 10 GM/15 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    50383079216 VALPROIC ACID 250 MG/5 ML SOLN

    Pricing Unit: ML | Drug Type:

    50383007916 ACETAMINOPHEN-CODEINE 120 MG-12 MG/5 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    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
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