NDC codes

FDA NDC Directory
Product NDC (as listed)70709-085Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70709-0085Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70709-085-107070900851070709008510100 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.NDC labeler code 70709
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

N470709008510 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 70709-085

What is NDC 70709-085?
70709-085 is the product NDC for Ormalvi (dichlorphenamide), Dichlorphenamide 50 mg/1 tablet, listed with the FDA by Cycle Pharmaceuticals Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ormalvi (Dichlorphenamide).
What is the active ingredient?
Dichlorphenamide.
Who is the labeler?
Cycle Pharmaceuticals Ltd., NDC labeler code 70709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ormalvi?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 215924

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215924
ProductStrengthForm · routeLabelerProduct NDC
DichlorphenamideDichlorphenamide 50 mg/1TabletOralTorrent pharmaceuticals limited13668-676

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