0054-0243 : Codeine Sulfate 15 mg Oral Tablet

Labeler: Roxane Laboratories, Inc
Product Type: Human Prescription Drug
Drug Name:  Codeine Sulfate
Dosage Form: Oral Tablet
Application #: NDA022402
Rev. Date: 
CSA Schedule: CII (US) [1]

[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.


Markings: 15;54;613
Shapes:  Round
Colors:  White
Size (mm): 6
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

Active Ingredients:

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Cellulose, Microcrystalline
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

Related Products:

Based on records with the same trade name.


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Note: The MedsChat® NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.