42254-140 : Prometh With Codeine Oral Syrup


NDC42254-140
Labeler: Rebel Distributors Corp
Product Type: Human Prescription Drug
Drug Name: Prometh With Codeine
Dosage Form: Oral Syrup
Application #: ANDA088763
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:

  • 42254-140-04: 118 ML IN 1 BOTTLE (42254‑140‑04)

Active Ingredients:

  • Codeine Phosphate
  • Promethazine Hydrochloride

Dosage Strength:

  • 10 mg/5mL
  • 6.25 mg/5mL

Pharmaceutical Classes:

  • Phenothiazine [EPC]
  • Phenothiazines [CS]

Related Products:

Based on records with the same trade name.
  • 0472-1627 Prometh With Codeine Oral Syrup by Actavis Mid Atlantic LLC
  • 52125-596 Prometh With Codeine Oral Syrup by Remedyrepack Inc.
  • 63629-1607 Prometh With Codeine Oral Syrup by Bryant Ranch Prepack

NDC QR Code

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