Prescription drug · ANDA
Ormalvi (dichlorphenamide) NDC 70709-085
Dichlorphenamide 50 mg/1 · Tablet · Oral · Cycle Pharmaceuticals Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70709-085-10 | 70709008510 | 100 TABLET in 1 BOTTLE (70709-085-10)Marketed from Mar 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ormalvi
- Generic name (nonproprietary)
- dichlorphenamide
- Active ingredients
- Dichlorphenamide — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cycle Pharmaceuticals Ltd.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215924
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 70709-085_8716de8d-f4b6-4192-892c-cb22b511257cSPL ID 8716de8d-f4b6-4192-892c-cb22b511257cSPL set ID 3989e220-6502-449b-be39-e2689acce08cRxCUI 197594, 2677447UNII VVJ6673MHYUPC 0370709085104
- Pharmacologic class
- Carbonic Anhydrase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470709008510followed by a unit qualifier and the quantityPackage 70709-0085-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ORMALVI is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. ORMALVI is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215924
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dichlorphenamide | Dichlorphenamide 50 mg/1 | TabletOral | Torrent pharmaceuticals limited | 13668-676 |