70518-2628 : Acetaminophen and Codeine Phosphate Oral Tablet


NDC: 70518-2628
Labeler: Remedyrepack Inc.
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine Phosphate
Dosage Form: Oral Tablet
Application #: ANDA211610
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: W242
Shapes:  Round
Colors:  White
Size (mm): 12
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.

NDC Package Codes:

  • 70518-2628-0: 30 TABLET IN 1 BLISTER PACK (70518‑2628‑0)
  • 70518-2628-1: 30 TABLET IN 1 BLISTER PACK (70518‑2628‑1)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 300 mg
  • 30 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Silicon Dioxide
  • Magnesium Stearate
  • Starch, Corn
  • Povidone
  • Crospovidone
  • Stearic Acid /

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
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  • 70518-1592 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-2764 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-2989 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-3051 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-3575 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-3705 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 70518-4104 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 24236-009 Acetaminophen and Codeine Phosphate (Acetaminophen 300 mg) by Remedyrepack Inc.
  • 61786-182 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 61786-259 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 61786-304 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 61786-421 Acetaminophen and Codeine Phosphate Oral Tablet by Remedyrepack Inc.
  • 0093-0050 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0150 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0350 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0121-0504 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-1008 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
  • 0406-0483 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-0484 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Mallinckrodt, Inc.
  • More related products ...

NDC QR Code

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NDC 70518-2628 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.