54569-0025 : Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet


NDC: 54569-0025
Labeler: A-s Medication Solutions LLC
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine
Dosage Form: Oral Tablet
Application #: ANDA089805
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: 2064;V;3
Shapes:  Round
Colors:  White
Size (mm): 10
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.

2064 V 3: (0603-2338) Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by A-s Medication Solutions LLC
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:

  • 54569-0025-0: 10 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑0)
  • 54569-0025-1: 12 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑1)
  • 54569-0025-2: 15 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑2)
  • 54569-0025-3: 20 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑3)
  • 54569-0025-4: 30 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑4)
  • 54569-0025-6: 6 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑6)
  • 54569-0025-7: 100 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑7)
  • 54569-0025-9: 24 TABLET IN 1 BOTTLE, PLASTIC (54569‑0025‑9)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 300 mg
  • 30 mg

Inactive Ingredients:

  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidones
  • Starch, Corn
  • Sodium Metabisulfite
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54569-0302 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by A-s Medication Solutions LLC
  • 54569-0311 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by A-s Medication Solutions LLC
  • 54569-2523 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by A-s Medication Solutions LLC
  • 54569-8305 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • 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
  • 50090-0067 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • 50090-0085 Acetaminophen and Codeine Oral Tablet by A-s Medication Solutions LLC
  • 0440-7026 Acetaminophen and Codeine Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 0440-7027 Acetaminophen and Codeine Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 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
  • 0603-9013 Acetaminophen and Codeine Oral Solution by Qualitest Pharmaceuticals
  • 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.
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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.