42192-612 : Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution


NDC: 42192-612
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]

NDC 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.