NDC 10544-100

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 Blenheim Pharmacal, Inc.. The primary component is Acetaminophen; Codeine Phosphate.

Product ID10544-100_21c498e0-47f1-4958-9126-86ddde5f2d78
NDC10544-100
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen and Codeine
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-11-11
Marketing CategoryANDA / ANDA
Application NumberANDA089805
Labeler NameBlenheim Pharmacal, Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Active Ingredient Strength300 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-100-10

10 TABLET in 1 BOTTLE (10544-100-10)
Marketing Start Date2013-11-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-100-20 [10544010020]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-04
Inactivation Date2019-11-27

NDC 10544-100-15 [10544010015]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-11-11
Inactivation Date2019-11-27

NDC 10544-100-10 [10544010010]

Acetaminophen and Codeine TABLET
Marketing CategoryANDA
Application NumberANDA089805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-04
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:fdea5078-b6d3-4c2b-981b-398bb1fadc40
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993781
    • UPC Code
  • 0310544100204

    • 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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