NDC 50458-513

TYLENOL with Codeine

Acetaminophen And Codeine Phosphate

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

Product ID50458-513_072c13e0-7ea7-11e8-bdfb-43999d46d017
NDC50458-513
Product TypeHuman Prescription Drug
Proprietary NameTYLENOL with Codeine
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1977-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA085055
Labeler NameJanssen 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 50458-513-60

100 TABLET in 1 BOTTLE (50458-513-60)
Marketing Start Date1977-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-513-60 [50458051360]

TYLENOL with Codeine TABLET
Marketing CategoryANDA
Application NumberANDA085055
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1977-08-17
Marketing End Date2020-06-30

NDC 50458-513-80 [50458051380]

TYLENOL with Codeine TABLET
Marketing CategoryANDA
Application NumberANDA085055
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1977-08-17
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:936e481e-f46c-4e03-b8e3-25961cda1909
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993892
  • 993890
  • 993837
  • 993781
    • UPC Code
  • 0350458513608
  • 0350458515602

    • Pharmacological Class

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

    Medicade Reported Pricing

    50458051380 TYLENOL WITH CODEINE #3 TABLET

    Pricing Unit: EA | Drug Type:

    50458051360 TYLENOL WITH CODEINE #3 TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "TYLENOL with Codeine" or generic name "Acetaminophen And Codeine Phosphate"

    NDCBrand NameGeneric Name
    50090-0006TYLENOL with CodeineTYLENOL with Codeine
    50458-515TYLENOL with CodeineTYLENOL with Codeine
    50458-513TYLENOL with CodeineTYLENOL with Codeine
    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
    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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