0603-9013 : Acetaminophen and Codeine Oral Solution


NDC: 0603-9013
Labeler: Qualitest Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine
Dosage Form: Oral Solution
Application #: ANDA091238
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 0603-9013-54: 120 ML IN 1 BOTTLE (0603‑9013‑54)
  • 0603-9013-58: 473 ML IN 1 BOTTLE (0603‑9013‑58)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 120 mg/5mL
  • 12 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0603-2337 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-2338 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-2339 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0440-7026 Acetaminophen and Codeine Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 0440-7027 Acetaminophen and Codeine Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 10544-100 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 16590-023 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Stat Rx USA LLC
  • 33261-001 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 33261-002 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 33358-001 Acetaminophen and Codeine Oral Tablet by Rxchange Co.
  • 33358-002 Acetaminophen and Codeine Oral Tablet by Rxchange Co.
  • 43063-014 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-139 Acetaminophen and Codeine Oral Solution by Pd-rx Pharmaceuticals, Inc.
  • 43063-554 Acetaminophen and Codeine Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-586 Acetaminophen and Codeine Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43353-010 Acetaminophen and Codeine Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 49349-926 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Remedyrepack Inc.
  • 50090-0007 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • 50090-0008 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • 50090-0009 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • More related products ...

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.