What is NDC 81583-100?

81583-100 is the product NDC for Ztalmy (ganaxolone), Ganaxolone 50 mg/mL suspension, listed with the FDA by Immedica Pharma US Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Immedica Pharma US Inc, NDC labeler code 81583. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ztalmy?

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.

Ztalmy NDC 81583-100 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81583-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81583-0100Add 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 NDC	11-digit (billing)	Package	Copy
81583-100-01	81583010001	1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTICMarketed from Jun 6, 2022

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): Ztalmy
Generic name (nonproprietary): ganaxolone
Active ingredients: Ganaxolone — 50 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Immedica Pharma US IncNDC labeler code 81583
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215904
Marketing start: Jun 6, 2022
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: GABA A Receptor Positive Modulators (Mechanism)
Identifiers: Product ID 81583-100_7733b399-cf1c-4408-9825-87d4875f5332SPL ID 7733b399-cf1c-4408-9825-87d4875f5332
Pharmacologic class: Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator

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

N481583010001 followed by a unit qualifier and the quantity

Package 81583-0100-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 81583-100

What is NDC 81583-100?: 81583-100 is the product NDC for Ztalmy (ganaxolone), Ganaxolone 50 mg/mL suspension, listed with the FDA by Immedica Pharma US Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ztalmy (Ganaxolone).
What is the active ingredient?: Ganaxolone.
Who is the labeler?: Immedica Pharma US Inc, NDC labeler code 81583. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ztalmy?: 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.

Ztalmy (Ganaxolone) NDC 81583-100