0054-9628 : N/A .5 g/ml Oral Solution


NDC: 0054-9628
Labeler: Hikma Pharmaceuticals USA Inc.
Product Type: Human Prescription Drug
Drug Name:  N/A
Dosage Form: Oral Solution
Application #: NDA021196
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 0054-9628-57: 180 ML IN 1 BOTTLE, PLASTIC (0054‑9628‑57)

Active Ingredients:

  • Sodium Oxybate

Dosage Strength:

  • .5 g/mL

Pharmaceutical Classes:

  • Central Nervous System Depressant [EPC]
  • Central Nervous System Depression [PE]
  • Decreased Central Nervous System Organized Electrical Activity [PE]

Related Products:

Based on records with the same trade name.
  • 0517-0920 N/A 6 mg/ml Intravenous Injection by American Regent, Inc.
  • 43386-405 N/A 500 mg Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 71053-590 N/A .5 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 71053-591 N/A 1 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 71053-592 N/A 2 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 71053-595 N/A 10 mg/.7ml Intramuscular Injection, Solution by Rafa Laboratories, Ltd.

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.