72865-169 : Hydromorphone Hydrochloride 12 mg Oral Tablet, Extended Release


NDC: 72865-169
Labeler: Xlcare Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydromorphone Hydrochloride
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA212133
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:

  • 72865-169-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (72865‑169‑01)

Active Ingredients:

  • Hydromorphone Hydrochloride

Dosage Strength:

  • 12 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 72865-168 Hydromorphone Hydrochloride 8 mg Oral Tablet, Extended Release by Xlcare Pharmaceuticals, Inc.
  • 72865-170 Hydromorphone Hydrochloride 16 mg Oral Tablet, Extended Release by Xlcare Pharmaceuticals, Inc.
  • 72865-171 Hydromorphone Hydrochloride 32 mg Oral Tablet, Extended Release by Xlcare Pharmaceuticals, Inc.
  • 0054-0264 Hydromorphone Hydrochloride 4 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0265 Hydromorphone Hydrochloride 8 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0386 Hydromorphone Hydrochloride 1 mg/ml Oral Solution by Roxane Laboratories, Inc
  • 0406-3243 Hydromorphone Hydrochloride 2 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-3244 Hydromorphone Hydrochloride 4 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-3249 Hydromorphone Hydrochloride 8 mg Oral Tablet by Mallinckrodt, Inc.
  • 0409-1283 Hydromorphone Hydrochloride 1 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-1304 Hydromorphone Hydrochloride 4 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-1312 Hydromorphone Hydrochloride 2 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-1805 Hydromorphone Hydrochloride .25 mg/.5ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-2540 Hydromorphone Hydrochloride 4 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-2552 Hydromorphone Hydrochloride 1 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-2634 Hydromorphone Hydrochloride 10 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-3356 Hydromorphone Hydrochloride 2 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-3365 Hydromorphone Hydrochloride 2 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-3459 Hydromorphone Hydrochloride 2 mg/ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • 0409-4264 Hydromorphone Hydrochloride .5 mg/.5ml Intramuscular; Intravenous; Subcutaneous Injection, Solution by Hospira, Inc.
  • More related products ...

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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.