NDC 68788-9403

Acetaminophen and Codeine

Acetaminophen And Codeine

Acetaminophen and Codeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Acetaminophen; Codeine Phosphate.

Product ID68788-9403_34139adb-ed49-4a6f-9b58-7f1990ceeac6
NDC68788-9403
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen and Codeine
Generic NameAcetaminophen And Codeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA040779
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Active Ingredient Strength300 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9403-1

15 TABLET in 1 BOTTLE (68788-9403-1)
Marketing Start Date2014-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9403-6 [68788940306]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-17
Marketing End Date2020-02-11

NDC 68788-9403-2 [68788940302]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-17
Marketing End Date2020-02-11

NDC 68788-9403-9 [68788940309]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-17
Marketing End Date2020-02-11

NDC 68788-9403-3 [68788940303]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-17
Marketing End Date2020-02-11

NDC 68788-9403-1 [68788940301]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-17
Marketing End Date2020-02-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:a3c98d44-c77e-42ef-a52c-f46cacca7763
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993781

    • Pharmacological Class

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

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

    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
    0603-2339Acetaminophen And Codeineacetaminophen and codeine phosphate
    10544-100Acetaminophen and Codeineacetaminophen and codeine phosphate
    33261-001Acetaminophen And Codeineacetaminophen and codeine phosphate
    33261-002Acetaminophen And Codeineacetaminophen and codeine phosphate
    33358-002Acetaminophen And Codeineacetaminophen and codeine phosphate
    43353-010Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1572Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1573Acetaminophen and CodeineAcetaminophen and Codeine
    50090-1574Acetaminophen and CodeineAcetaminophen and Codeine
    50436-3227Acetaminophen and CodeineAcetaminophen and Codeine
    51655-802ACETAMINOPHEN AND CODEINECodeine Phosphate and APAP
    51655-808Acetaminophen and CodeineAcetaminophen and Codeine
    52959-003Acetaminophen And Codeineacetaminophen and codeine phosphate
    52959-446Acetaminophen and Codeineacetaminophen and codeine phosphate
    53002-0101Acetaminophen and CodeineAcetaminophen and Codeine
    53489-159ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
    53489-160ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
    53489-161ACETAMINOPHEN AND CODEINEAcetaminophen and Codeine Phosphate
    61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-472ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINE
    63187-470Acetaminophen 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
    71335-0545Acetaminophen and CodeineAcetaminophen and Codeine
    63187-491Acetaminophen 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
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