35356-389 : 12 Hr Opana 20 mg Extended Release Tablet


NDC35356-389
Labeler: Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
Product Type: Human Prescription Drug
Drug Name:  Opana ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA021610
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: 20
Shapes:  Octagon (8 sides)
Colors:  Green
Size (mm): 8
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:

  • 35356-389-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (35356‑389‑30)
  • 35356-389-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (35356‑389‑60)

Active Ingredients:

  • Oxymorphone Hydrochloride

Dosage Strength:

  • 20 mg

Inactive Ingredients:

  • Hypromelloses
  • Methylparaben
  • Sodium Stearyl Fumarate
  • Titanium Dioxide
  • Triacetin
  • Polyethylene Glycol
  • Polysorbate 80
  • Fd&c Blue No. 1
  • Fd&c Yellow No. 6
  • D&c Yellow No. 10

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 35356-380 Opana 10 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-388 12 Hr Opana 10 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-391 12 Hr Opana 40 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-403 12 Hr Opana 30 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-499 Opana 5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-820 12 Hr Opana 10 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-825 12 Hr Opana 20 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-848 12 Hr Opana 40 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-849 12 Hr Opana 30 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 16590-609 12 Hr Opana 40 mg Extended Release Tablet by Stat Rx USA LLC
  • 16590-747 12 Hr Opana 10 mg Extended Release Tablet by Stat Rx USA LLC
  • 16590-765 Opana 10 mg Oral Tablet by Stat Rx USA LLC
  • 16590-767 12 Hr Opana 5 mg Extended Release Tablet by Stat Rx USA LLC
  • 63481-434 12 Hr Opana 5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-435 12 Hr Opana 7.5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-436 12 Hr Opana 10 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-437 12 Hr Opana 15 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-438 12 Hr Opana 20 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-439 12 Hr Opana 30 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-440 12 Hr Opana 40 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • More related products ...

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.