54868-6388 : 24 Hr Exalgo 16 mg Extended Release Tablet

Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Exalgo
Dosage Form: Oral Tablet, Extended Release
Application #: NDA021217
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.


Markings: EXH;16
Shapes:  Round
Colors:  Yellow
Size (mm): 9
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54868-6388-0: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54868‑6388‑0)

Active Ingredients:

  • Hydromorphone Hydrochloride

Dosage Strength:

  • 16 mg

Inactive Ingredients:

  • Butylated Hydroxytoluene
  • Cellulose Acetate
  • Ferrosoferric Oxide
  • Ferric Oxide Yellow
  • Hypromellose 2910 (5 Mpa.s)
  • Anhydrous Lactose
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyethylene Glycols
  • Povidones
  • Sodium Chloride
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54868-6387 24 Hr Exalgo 8 mg Extended Release Tablet by Physicians Total Care, Inc.
  • 16590-942 24 Hr Exalgo 8 mg Extended Release Tablet by Stat Rx USA LLC
  • 23635-408 24 Hr Exalgo 8 mg Extended Release Tablet by Mallinckrodt, Inc
  • 23635-412 24 Hr Exalgo 12 mg Extended Release Tablet by Mallinckrodt, Inc
  • 23635-416 24 Hr Exalgo 16 mg Extended Release Tablet by Mallinckrodt, Inc
  • 23635-432 24 Hr Exalgo 32 mg Extended Release Tablet by Mallinckrodt, Inc
  • 35356-608 24 Hr Exalgo 12 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-609 24 Hr Exalgo 16 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-610 24 Hr Exalgo 8 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC


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