46672-648 : Oxycodone Hydrochloride and Acetaminophen Oral Solution


NDC: 46672-648
Labeler: Mikart, LLC
Product Type: Human Prescription Drug
Drug Name: Oxycodone Hydrochloride and Acetaminophen
Dosage Form: Oral Solution
Application #: ANDA202142
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:

  • 46672-648-04: 120 ML IN 1 BOTTLE, PLASTIC (46672‑648‑04)
  • 46672-648-55: 500 ML IN 1 BOTTLE, PLASTIC (46672‑648‑55)

Active Ingredients:

  • Oxycodone Hydrochloride
  • Acetaminophen

Dosage Strength:

  • 10 mg/5mL
  • 300 mg/5mL

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0054-2795 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Roxane Laboratories, Inc
  • 0603-1492 Oxycodone Hydrochloride and Acetaminophen Oral Solution by Qualitest Pharmaceuticals
  • 0603-4997 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Qualitest Pharmaceuticals
  • 29033-405 Oxycodone Hydrochloride and Acetaminophen Oral Solution by Nostrum Laboratories, Inc.
  • 42549-618 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-640 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Stat Rx USA LLC
  • 43063-025 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 60760-200 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by St. Mary's Medical Park Pharmacy
  • 64850-621 Oxycodone Hydrochloride and Acetaminophen Oral Tablet by Elite Laboratories, Inc.
  • 64850-622 Oxycodone Hydrochloride and Acetaminophen Oral Tablet by Elite Laboratories, Inc.
  • 64850-623 Oxycodone Hydrochloride and Acetaminophen Oral Tablet by Elite Laboratories, Inc.
  • 72887-648 Oxycodone Hydrochloride and Acetaminophen Oral Solution by Fh2 Pharma LLC

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