68025-076 : Osmolex ER 193 mg Oral Tablet, Extended Release


NDC68025-076
Labeler: Vertical Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name:  Osmolex ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA209410
Rev. Date: 


Appearance:


Markings: VP076
Shapes:  Round
Colors:  Green
Size (mm): 10
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:

  • 68025-076-14: 2 BLISTER PACK IN 1 CARTON (68025‑076‑14) > 7 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK (68025‑076‑07)
  • 68025-076-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑076‑30)
  • 68025-076-90: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68025‑076‑90)

Active Ingredients:

  • Amantadine

Dosage Strength:

  • 193 mg

Inactive Ingredients:

  • 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 /

Pharmaceutical Classes:

  • Influenza A M2 Protein Inhibitor [EPC]
  • M2 Protein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 68025-021 Osmolex ER 161 mg Oral Tablet, Extended Release by Vertical Pharmaceuticals, LLC
  • 68025-074 Osmolex EROsmolex ER Kit by Vertical Pharmaceuticals, LLC
  • 68025-075 Osmolex ER 129 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.