NDC 0603-2338

Acetaminophen And Codeine

Acetaminophen And Codeine Phosphate

Acetaminophen And Codeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Codeine Phosphate; Acetaminophen.

Product ID0603-2338_3809e549-9586-4a30-b20b-a01c08d9869d
NDC0603-2338
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen And Codeine
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1988-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA089805
Labeler NamePar Pharmaceutical
Substance NameCODEINE PHOSPHATE; ACETAMINOPHEN
Active Ingredient Strength30 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0603-2338-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-2338-21)
Marketing Start Date1988-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-2338-20 [00603233820]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Marketing End Date2017-10-31

NDC 0603-2338-16 [00603233816]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Marketing End Date2017-10-31

NDC 0603-2338-32 [00603233832]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30

NDC 0603-2338-02 [00603233802]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Marketing End Date2017-10-31

NDC 0603-2338-21 [00603233821]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30

NDC 0603-2338-19 [00603233819]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-09-30
Marketing End Date2011-02-28

NDC 0603-2338-04 [00603233804]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Marketing End Date2017-10-31

NDC 0603-2338-22 [00603233822]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Marketing End Date2017-10-31

NDC 0603-2338-28 [00603233828]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-09-30
Marketing End Date2017-02-23

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE30 mg/1

OpenFDA Data

SPL SET ID:afb118ae-3841-4d0a-aef4-17f05cb6f9be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993890
  • 993781
  • UPC Code
  • 0306032339218
  • 0306032338211
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0440-7026Acetaminophen And Codeineacetaminophen and codeine phosphate
    0440-7027Acetaminophen And Codeineacetaminophen and codeine phosphate
    0603-2337Acetaminophen And Codeineacetaminophen and codeine phosphate
    0603-2338Acetaminophen And Codeineacetaminophen and codeine phosphate
    68071-3059Acetaminophen and CodeineAcetaminophen and Codeine
    68387-250Acetaminophen And CodeineAcetaminophen And Codeine
    68788-9403Acetaminophen and CodeineAcetaminophen and Codeine
    68788-9259Acetaminophen And CodeineAcetaminophen And Codeine
    0603-2339Acetaminophen And CodeineAcetaminophen And Codeine
    71335-0545Acetaminophen and CodeineAcetaminophen and Codeine
    10544-100Acetaminophen and CodeineAcetaminophen and Codeine
    33261-001Acetaminophen And CodeineAcetaminophen And Codeine
    33261-002Acetaminophen And CodeineAcetaminophen And Codeine
    33358-002Acetaminophen And CodeineAcetaminophen And Codeine
    43353-010Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1573Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1574Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1572Acetaminophen and CodeineAcetaminophen and Codeine
    50436-3227Acetaminophen and CodeineAcetaminophen and Codeine
    51655-802ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    51655-808Acetaminophen and CodeineAcetaminophen and Codeine
    52959-003Acetaminophen And CodeineAcetaminophen And Codeine
    52959-446Acetaminophen and CodeineAcetaminophen and Codeine
    53489-160ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    53002-0101Acetaminophen and CodeineAcetaminophen and Codeine
    53489-159ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    53489-161ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-472ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    63187-491Acetaminophen and CodeineAcetaminophen and Codeine
    63187-470Acetaminophen And CodeineAcetaminophen And Codeine
    65162-033Acetaminophen and CodeineAcetaminophen and Codeine
    66267-001Acetaminophen and CodeineAcetaminophen and Codeine
    66267-759Acetaminophen and CodeineAcetaminophen and Codeine
    66336-059Acetaminophen And CodeineAcetaminophen And Codeine
    67046-902Acetaminophen And CodeineAcetaminophen And Codeine
    67046-908Acetaminophen and CodeineAcetaminophen and Codeine
    67296-0544Acetaminophen And CodeineAcetaminophen And Codeine
    67544-882Acetaminophen And CodeineAcetaminophen And Codeine
    67544-474Acetaminophen And CodeineAcetaminophen And Codeine
    61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.