0121-0504 : Acetaminophen and Codeine Phosphate Oral Solution


NDC: 0121-0504
Labeler: Pharmaceutical Associates, Inc.
Product Type: Human Prescription Drug
Drug Name: Acetaminophen and Codeine Phosphate
Dosage Form: Oral Solution
Application #: ANDA087508
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:

  • 0121-0504-00: 10 TRAY IN 1 CASE (0121‑0504‑00) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE (0121‑0504‑05)
  • 0121-0504-04: 118 ML IN 1 BOTTLE (0121‑0504‑04)
  • 0121-0504-05: 10 TRAY IN 1 CASE (0121‑0504‑05) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE
  • 0121-0504-10: 10 TRAY IN 1 CASE (0121‑0504‑10) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 10 ML IN 1 CUP, UNIT‑DOSE
  • 0121-0504-12: 10 TRAY IN 1 CASE (0121‑0504‑12) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 12.5 ML IN 1 CUP, UNIT‑DOSE
  • 0121-0504-15: 10 TRAY IN 1 CASE (0121‑0504‑15) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 15 ML IN 1 CUP, UNIT‑DOSE
  • 0121-0504-16: 473 ML IN 1 BOTTLE (0121‑0504‑16)

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.
  • 0121-1008 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, 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
  • 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.
  • 0406-0485 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Mallinckrodt, Inc.
  • 0603-1020 Acetaminophen and Codeine Phosphate Oral Solution by Qualitest Pharmaceuticals
  • 0615-7792 Acetaminophen and Codeine Phosphate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-8102 Acetaminophen and Codeine Phosphate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0785-6270 Apap 650 mg / Codeine Phosphate 60 mg Oral Tablet by Uad Laboratories
  • 10544-032 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 12634-266 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Apotheca, Inc.
  • 12634-267 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Apotheca, Inc.
  • 12634-526 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Apotheca, Inc.
  • 12634-975 Acetaminophen and Codeine Phosphate Oral Solution by Apotheca, Inc.
  • 13107-058 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Aurolife Pharma, LLC
  • 13107-059 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Aurolife Pharma, LLC
  • 13107-060 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Aurolife Pharma, LLC
  • 16590-361 Acetaminophen and Codeine Phosphate Oral Solution by Stat Rx USA LLC
  • More related products ...

NDC QR Code

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