NDC 0527-1698

Codeine Sulfate

Codeine Sulfate

Codeine Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Codeine Sulfate.

Product ID0527-1698_3db82243-1649-4470-91af-af12a932f456
NDC0527-1698
Product TypeHuman Prescription Drug
Proprietary NameCodeine Sulfate
Generic NameCodeine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA203046
Labeler NameLannett Company, Inc.
Substance NameCODEINE SULFATE
Active Ingredient Strength30 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0527-1698-01

100 TABLET in 1 BOTTLE (0527-1698-01)
Marketing Start Date2014-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1698-91 [00527169891]

Codeine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA203046
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-13

NDC 0527-1698-01 [00527169801]

Codeine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA203046
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-13

Drug Details

Active Ingredients

IngredientStrength
CODEINE SULFATE30 mg/1

OpenFDA Data

SPL SET ID:5819bdf7-300e-45b8-8f3a-447b53656293
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997287
  • 997170
  • 997296
  • UPC Code
  • 0305271698018
  • 0305271699015
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Codeine Sulfate" or generic name "Codeine Sulfate"

    NDCBrand NameGeneric Name
    0054-0243Codeine sulfatecodeine sulfate
    0054-0244Codeine sulfatecodeine sulfate
    0054-0245Codeine sulfatecodeine sulfate
    0527-1698Codeine SulfateCodeine Sulfate
    0527-1699Codeine SulfateCodeine Sulfate
    0527-1727Codeine SulfateCodeine Sulfate

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