68025-074 : Osmolex EROsmolex ER Kit
| NDC: | 68025-074 |
| Labeler: | Vertical Pharmaceuticals, LLC |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Osmolex ER |
| Dosage Form: | Kit |
| Application #: | NDA209410 |
| Rev. Date: |
Appearance:
| Markings: | VP075 VP076 |
| Shapes: |
Round |
| Colors: |
 White Green |
| Size (mm): | 10 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:
- 68025-074-62: 1 KIT IN 1 CARTON (68025‑074‑62) * 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑075‑30) * 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑076‑30)
Active Ingredients:
- Amantadine
Kit Contents:
- Osmolex ER
Inactive Ingredients:
- Cellulose Acetate
- Silicon Dioxide
- Copovidone K25-31
- Magnesium Stearate
- Microcrystalline Cellulose
- Ferrosoferric Oxide
- Hypromelloses
- Propylene Glycol
- Polyethylene Glycol 400
- Titanium Dioxide
- D&c Yellow No. 10
- Polysorbate 80
- Fd&c Yellow No. 6
- Sodium Chloride
- Lactose Monohydrate
- Triacetin /
- Cellulose Acetate
- Silicon Dioxide
- Copovidone K25-31
- Magnesium Stearate
- Microcrystalline Cellulose
- Ferrosoferric Oxide
- Propylene Glycol
- Hypromelloses
- Polyethylene Glycol 400
- Titanium Dioxide
- Polysorbate 80
- D&c Yellow No. 10
- Fd&c Yellow No. 6
- Sodium Chloride
- Fd&c Blue No. 2
- Fd&c Red No. 40 /
Related Products:
Based on records with the same trade name.- 68025-021 Osmolex ER 161 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
- 68025-075 Osmolex ER 129 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
- 68025-076 Osmolex ER 193 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
- 68025-077 Osmolex ER 258 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
- 70482-075 Osmolex ER 129 mg Oral Tablet, Extended Release by Adamas Pharma, LLC
- 70482-076 Osmolex ER 129 mg Oral Tablet, Extended Release by Adamas Pharma, LLC
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.