57664-185 : Promethazine Hydrochloride and Codeine Phosphate Oral Syrup


NDC: 57664-185
Labeler: Caraco Pharmaceutical Laboratories, Ltd.
Product Type: Human Prescription Drug
Drug Name: Promethazine Hydrochloride and Codeine Phosphate
Dosage Form: Oral Syrup
Application #: ANDA090180
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:

  • 57664-185-31: 118 ML IN 1 BOTTLE (57664‑185‑31)
  • 57664-185-34: 473 ML IN 1 BOTTLE (57664‑185‑34)

Active Ingredients:

  • Codeine Phosphate
  • Promethazine Hydrochloride

Dosage Strength:

  • 10 mg/5mL
  • 6.25 mg/5mL

Pharmaceutical Classes:

  • Phenothiazine [EPC]
  • Phenothiazines [Chemical/Ingredient]
  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0121-0547 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Pharmaceutical Associates, Inc.
  • 12634-907 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Apotheca, Inc
  • 17856-0065 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Atlantic Biologicals Corp.
  • 17856-0139 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Atlantic Biologicals Corp.
  • 17856-0804 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Atlantic Biologicals Corps
  • 27808-065 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Tris Pharma Inc
  • 50090-1482 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by A-s Medication Solutions LLC
  • 50383-804 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Hi-tech Pharmacal Co., Inc.
  • 52125-587 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Remedyrepack Inc.
  • 63187-595 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Proficient Rx Lp
  • 65162-695 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Amneal Pharmaceuticals LLC
  • 68788-9385 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Preferred Pharmaceuticals, Inc.
  • 70408-185 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Nostrum Laboratories, Inc.
  • 70752-139 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Quagen Pharmaceuticals LLC
  • 72162-2042 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Bryant Ranch Prepack

NDC QR Code

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NDC 57664-185 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.