0406-3332 : Hydromorphone Hydrochloride 32 mg Oral Tablet, Extended Release


NDC0406-3332
Labeler: Mallinckrodt, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydromorphone Hydrochloride Extended-release
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.

Appearance:


Markings: EXH;32
Shapes:  Round
Colors:  White
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:

  • 0406-3332-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (0406‑3332‑01)

Active Ingredients:

  • Hydromorphone Hydrochloride

Dosage Strength:

  • 32 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.
  • 0406-3308 Hydromorphone Hydrochloride 8 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
  • 0406-3312 Hydromorphone Hydrochloride 12 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
  • 0406-3316 Hydromorphone Hydrochloride 16 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
  • 55700-400 Hydromorphone Hydrochloride Extended-release 16 mg Oral Tablet, Extended Release by Lake Erie Medical Dba Quality Care Products LLC

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.