NDC 0054-0244

Codeine sulfate

Codeine Sulfate

Codeine sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Codeine Sulfate.

Product ID0054-0244_45ae2b1b-8f8f-4189-af20-72b61d46298b
NDC0054-0244
Product TypeHuman Prescription Drug
Proprietary NameCodeine sulfate
Generic NameCodeine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-16
Marketing CategoryNDA / NDA
Application NumberNDA022402
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameCODEINE SULFATE
Active Ingredient Strength30 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0244-24

10 BLISTER PACK in 1 BOX (0054-0244-24) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2009-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0244-24 [00054024424]

Codeine sulfate TABLET
Marketing CategoryNDA
Application NumberNDA022402
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-16

NDC 0054-0244-25 [00054024425]

Codeine sulfate TABLET
Marketing CategoryNDA
Application NumberNDA022402
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-16

Drug Details

Active Ingredients

IngredientStrength
CODEINE SULFATE30 mg/1

OpenFDA Data

SPL SET ID:010905f9-3bcb-4b50-9fe8-a3ad0010f14c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997287
  • 997296
  • UPC Code
  • 0300540244255
  • 0300540245252
  • 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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