16590-747 : 12 Hr Opana 10 mg Extended Release Tablet
| NDC: | 16590-747 |
| Labeler: | Stat Rx USA LLC |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Opana ER |
| Dosage Form: | Oral Tablet, Film Coated, 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: | E674;10 |
| Shapes: |
Octagon (8 sides) |
| Colors: |
 Orange |
| Size (mm): | 8 |
| Segments: * | 2 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces. | |
NDC Package Codes:
- 16590-747-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑747‑30)
- 16590-747-56: 56 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑747‑56)
- 16590-747-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑747‑60)
- 16590-747-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑747‑90)
Active Ingredients:
- Oxymorphone Hydrochloride
Dosage Strength:
- 10 mg
Inactive Ingredients:
- Hypromelloses
- Methylparaben
- Propylene Glycol
- Sodium Stearyl Fumarate
- Titanium Dioxide
- Triacetin
- Fd&c Yellow No. 6
- Ferrosoferric Oxide
- Cellulose, Microcrystalline
- Polyethylene Glycols
- Polysorbate 80
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
Based on records with the same trade name.- 16590-609 12 Hr Opana 40 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
- 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
- 35356-389 12 Hr Opana 20 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
- 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 ...
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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.