NDC 52959-003

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 H.j. Harkins Company, Inc.. The primary component is Codeine Phosphate; Acetaminophen.

Product ID52959-003_75c9fa2e-a170-69f7-e053-2a91aa0ad11a
NDC52959-003
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 NameH.J. Harkins Company, Inc.
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 Through2019-12-31

Packaging

NDC 52959-003-02

120 TABLET in 1 BOTTLE, PLASTIC (52959-003-02)
Marketing Start Date1988-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-003-50 [52959000350]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-15 [52959000315]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-60 [52959000360]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-45 [52959000345]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-42 [52959000342]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-10 [52959000310]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-04 [52959000304]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-30 [52959000330]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-02 [52959000302]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-28 [52959000328]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-75 [52959000375]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-00 [52959000300]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-20 [52959000320]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-84 [52959000384]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-25 [52959000325]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-24 [52959000324]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-14 [52959000314]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-12 [52959000312]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-90 [52959000390]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-06 [52959000306]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-16 [52959000316]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

NDC 52959-003-40 [52959000340]

Acetaminophen And Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-09-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE30 mg/1

OpenFDA Data

SPL SET ID:97b0ee29-d08e-4d9b-82ed-3ce287dbec28
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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