NDC 43353-010

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

Product ID43353-010_8ade0dd7-67ee-45f4-9713-95d3991a5bd9
NDC43353-010
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen and Codeine
Generic NameAcetaminophen And Codeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA040779
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 43353-010-40

40 TABLET in 1 BOTTLE (43353-010-40)
Marketing Start Date2015-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-010-70 [43353001070]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

NDC 43353-010-40 [43353001040]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-06

NDC 43353-010-75 [43353001075]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

NDC 43353-010-45 [43353001045]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

NDC 43353-010-60 [43353001060]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

NDC 43353-010-50 [43353001050]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

NDC 43353-010-90 [43353001090]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA040779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-24

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:b84d3e24-693d-4667-ae35-0583b6368610
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.