61786-304 : Acetaminophen and Codeine Phosphate Oral Tablet
NDC: | 61786-304 |
Labeler: | Remedyrepack Inc. |
Product Type: | Human Prescription Drug |
Drug Name: | Acetaminophen and Codeine Phosphate |
Dosage Form: | Oral Tablet |
Application #: | ANDA088629 |
Rev. Date: | |
CSA Schedule: | CIII (US) [1] |
[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
Markings: | 4;93;350 |
Shapes: |
Round |
Colors: |
White |
Size (mm): | 10 |
Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. |
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:
- 61786-304-02: 30 TABLET IN 1 BLISTER PACK (61786‑304‑02)
Active Ingredients:
- Acetaminophen
- Codeine Phosphate
Dosage Strength:
- 300 mg
- 60 mg
Inactive Ingredients:
- Cellulose, Microcrystalline
- Crospovidone
- Magnesium Stearate
- Povidones
- Croscarmellose Sodium
- Silicon Dioxide
- Starch, Corn
- Stearic Acid
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
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- 70518-3051 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
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- 0121-0504 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
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- 0406-0483 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Mallinckrodt, Inc.
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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.