NDC 67544-474

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 Aphena Pharma Solutions - Tennessee, Llc. The primary component is Codeine Phosphate; Acetaminophen.

Product ID67544-474_6a62ad9a-c0ce-4848-81f3-159f525922a6
NDC67544-474
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 NumberANDA089828
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameCODEINE PHOSPHATE; ACETAMINOPHEN
Active Ingredient Strength60 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67544-474-30

30 TABLET in 1 BOTTLE, PLASTIC (67544-474-30)
Marketing Start Date2007-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-474-30 [67544047430]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-08-14

NDC 67544-474-60 [67544047460]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-02

NDC 67544-474-80 [67544047480]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-10-16

NDC 67544-474-53 [67544047453]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-11-17

NDC 67544-474-90 [67544047490]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-05

NDC 67544-474-70 [67544047470]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-02

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE60 mg/1

OpenFDA Data

SPL SET ID:1afe1bb3-6903-4785-a121-ac8aae8653a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993890
  • 993781

    • 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
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