NDC 64850-643

Acetaminophen and Codeine Phosphate

Acetaminophen And Codeine Phosphate

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

Product ID64850-643_278563f5-27f6-46d1-8f4b-206a7fa3d862
NDC64850-643
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen and Codeine Phosphate
Generic NameAcetaminophen And Codeine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA212418
Labeler NameElite Laboratories, 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 Through2020-12-31

Packaging

NDC 64850-643-12

120 TABLET in 1 BOTTLE (64850-643-12)
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64850-643-12 [64850064312]

Acetaminophen and Codeine Phosphate TABLET
Marketing CategoryANDA
Application NumberANDA212418
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:6286e128-1288-4dc0-b14b-f04a0e2a22f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993890
  • 993770
  • 993781
    • UPC Code
  • 0364850642125
  • 0364850643122
  • 0364850641128

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-3100Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-3061Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-3272Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-4475ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    68071-4430ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-4668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-4749Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68071-4533ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    68084-372Acetaminophen And Codeine PhosphateAcetaminophen And Codeine Phosphate
    68084-373Acetaminophen And Codeine PhosphateAcetaminophen And Codeine Phosphate
    68788-0076Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68788-0285Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68788-9300Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    68788-9506ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    68788-9736Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    70518-0212Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    70518-1592Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    71335-0256Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    71205-001Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    71335-0701Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    71335-0336Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    71610-111ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    0615-7792Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    0615-8102Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    10544-032ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    12634-975Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    12634-526ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    17856-0079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    21695-243ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    21695-242ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
    21695-547Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    33261-470Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    42254-145Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    42254-022Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    46672-561acetaminophen and codeine phosphateacetaminophen and codeine phosphate
    45865-439Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    45865-466Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate
    49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATE
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