60432-606 : Promethazine With Codeine Cough Oral Syrup


NDC: 60432-606
Labeler: Morton Grove Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Promethazine With Codeine Cough
Dosage Form: Oral Syrup
Application #: ANDA088875
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:

  • 60432-606-16: 473 ML IN 1 BOTTLE, PLASTIC (60432‑606‑16)

Active Ingredients:

  • Promethazine Hydrochloride
  • Codeine Phosphate

Dosage Strength:

  • 6.25 mg/5mL
  • 10 mg/5mL

Pharmaceutical Classes:

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

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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.