50458-657 : 24 Hr Ultram 300 mg Extended Release Tablet
| NDC: | 50458-657 |
| Labeler: | Janssen Pharmaceuticals, Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Ultram ER |
| Dosage Form: | Oral Tablet, Extended Release |
| Application #: | NDA021692 |
| Rev. Date: | |
| CSA Schedule: | CIV (US) [1] |
[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
| Markings: | 300;ER |
| 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. | |
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.
NDC Package Codes:
- 50458-657-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (50458‑657‑30)
Active Ingredients:
- Tramadol Hydrochloride
Dosage Strength:
- 300 mg
Inactive Ingredients:
- Dibutyl Sebacate
- Ethylcellulose (100 Mpa.s)
- Sodium Stearyl Fumarate
- Silicon Dioxide
- Polyvinyl Alcohol
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
Based on records with the same trade name.- 50458-653 24 Hr Ultram 100 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
- 50458-655 Ultram ER 200 mg 24 Hr Extended Release Tablet by Janssen Pharmaceuticals, Inc.
- 21695-292 24 Hr Ultram 100 mg Extended Release Tablet by Rebel Distributors Corp
- 21695-563 Ultram ER 200 mg 24 Hr Extended Release Tablet by Rebel Distributors Corp
- 21695-913 24 Hr Ultram 300 mg Extended Release Tablet by Rebel Distributors Corp
- 49999-896 Ultram ER 200 mg 24 Hr Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
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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.