NDC 61919-484

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 Direct Rx. The primary component is Acetaminophen; Codeine Phosphate.

Product ID61919-484_68941267-61fe-9072-e053-2a91aa0a39d5
NDC61919-484
Product TypeHuman Prescription Drug
Proprietary NameACETAMINOPHEN AND CODEINE
Generic NameAcetaminophen And Codeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA040419
Labeler NameDIRECT RX
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 61919-484-60

60 TABLET in 1 BOTTLE (61919-484-60)
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-484-30 [61919048430]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA040419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-14

NDC 61919-484-71 [61919048471]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA040419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

NDC 61919-484-60 [61919048460]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA040419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

NDC 61919-484-90 [61919048490]

ACETAMINOPHEN AND CODEINE TABLET
Marketing CategoryANDA
Application NumberANDA040419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:720570a4-9eec-41c8-ae69-37189756c318
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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