42192-612 : Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution


NDC42192-612
Labeler: Acella Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Chlorpheniramine Maleate
Dosage Form: Oral Solution
Application #: ANDA206891
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 42192-612-16: 480 ML IN 1 BOTTLE (42192‑612‑16)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Chlorpheniramine Maleate

Dosage Strength:

  • 5 mg/5mL
  • 4 mg/5mL

Pharmaceutical Classes:

  • Opioid Agonist [EPC]
  • Opioid Agonists [MoA]
  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

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