61919-818 : Tramadol Hcl 100 mg Oral Tablet, Extended Release
| NDC: | 61919-818 |
| Labeler: | Direct Rx |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Tramadol Hcl ER |
| Dosage Form: | Oral Tablet, Extended Release |
| Application #: | ANDA200503 |
| 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: | L010 |
| Shapes: |
Round |
| Colors: |
 White |
| Size (mm): | 6 |
| 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:
- 61919-818-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (61919‑818‑30)
- 61919-818-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (61919‑818‑60)
Active Ingredients:
- Tramadol Hydrochloride
Dosage Strength:
- 100 mg
Inactive Ingredients:
- Dibutyl Sebacate
- Ethylcelluloses
- Shellac
- Cellulose, Microcrystalline
- Ferrosoferric Oxide
- Povidone
- Propylene Glycol
- Silicon Dioxide
- Sodium Stearyl Fumarate /
Pharmaceutical Classes:
- Full Opioid Agonists [MoA]
- Opioid Agonist [EPC]
Related Products:
Based on records with the same trade name.- 72189-521 Tramadol Hcl ER 300 mg Oral Tablet, Extended Release by Direct_rx
- 80425-0108 Tramadol Hcl 100 mg Oral Tablet, Extended Release by Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0127 Tramadol Hcl 200 mg Oral Tablet, Extended Release by Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0136 Tramadol Hcl 200 mg Oral Tablet, Extended Release by Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0141 Tramadol Hcl 100 mg Oral Tablet, Extended Release by Advanced Rx Pharmacy of Tennessee, LLC
- 80425-0312 Tramadol Hcl 300 mg Oral Tablet, Extended Release by Advanced Rx Pharmacy of Tennessee, 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.