0054-0245 : Codeine Sulfate 60 mg Oral Tablet
| NDC: | 0054-0245 |
| 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.
Appearance:
| Markings: | 60;54;412 |
| Shapes: |
Round |
| Colors: |
 White |
| Size (mm): | 8 |
| 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. | |
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.
NDC Package Codes:
- 0054-0245-25: 100 TABLET IN 1 BOTTLE (0054‑0245‑25)
Active Ingredients:
- Codeine Sulfate
Dosage Strength:
- 60 mg
Inactive Ingredients:
- Silicon Dioxide
- Cellulose, Microcrystalline
- Starch, Corn
- Stearic Acid
- Silicon Dioxide
- Microcrystalline Cellulose
- Starch, Corn
- Stearic Acid
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
Based on records with the same trade name.- 0054-0243 Codeine Sulfate 15 mg Oral Tablet by Roxane Laboratories, Inc
- 0054-0244 Codeine Sulfate 30 mg Oral Tablet by Roxane Laboratories, Inc
- 0527-1698 Codeine Sulfate 30 mg Oral Tablet by Lannett Company, Inc.
- 0527-1699 Codeine Sulfate 60 mg Oral Tablet by Lannett Company, Inc.
- 0527-1727 Codeine Sulfate 15 mg Oral Tablet by Lannett Company, Inc.
- 51224-300 Codeine Sulfate 30 mg/5ml Oral Solution by Tagi Pharma, Inc.
- 54868-2541 Codeine Sulfate 60 mg Oral Tablet by Physicians Total Care, Inc.
- 68094-760 Codeine Sulfate 15 mg/2.5ml Oral Solution by Precision Dose Inc.
- 68094-761 Codeine Sulfate 30 mg/5ml Oral Solution by Precision Dose Inc.
NDC QR Code
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Note: The RxChat 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.