NDC 0054-0243

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 ID0054-0243_bcdb8c23-2436-47d0-83ea-980f99737927
NDC0054-0243
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 Strength15 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0243-24

10 BLISTER PACK in 1 BOX (0054-0243-24) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2009-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0243-24 [00054024324]

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

Drug Details

Active Ingredients

IngredientStrength
CODEINE SULFATE15 mg/1

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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