What is NDC 10122-210?

10122-210 is the product NDC for Myalept (metreleptin), Metreleptin 11.3 mg/2.2mL injection, powder, lyophilized, for solution, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Myalept?

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.

Myalept NDC 10122-210 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10122-210Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10122-0210Add 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
10122-210-02	10122021002	1 VIAL, GLASS in 1 CARTON (10122-210-02) / 2.2 mL in 1 VIAL, GLASSMarketed from Mar 5, 2015

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): Myalept
Generic name (nonproprietary): metreleptin
Active ingredients: Metreleptin — 11.3 mg/2.2mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Subcutaneous
Labeler: Chiesi USA, Inc.NDC labeler code 10122
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125390
Marketing start: Mar 5, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Analogs/Derivatives (Chemical/Ingredient)Leptin (Chemical/Ingredient)
Identifiers: Product ID 10122-210_8b236f4c-7654-49fe-bca9-ab947b72a1fdSPL ID 8b236f4c-7654-49fe-bca9-ab947b72a1fdSPL set ID d3b50bbd-140b-425c-b5ec-d4682aad62bcRxCUI 1491629, 1491634UNII TL60C27RLHUPC 0310122210028
Pharmacologic class: Leptin Analog

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N410122021002 followed by a unit qualifier and the quantity

Package 10122-0210-02. 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 Mar 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. ( 1 ) Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. ( 1 ) The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. ( 1 ) MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. ( 1 ) MYALEPT is not indicated for use in patients with metabolic disease, without concurrent evidence of genera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10122-210

What is NDC 10122-210?: 10122-210 is the product NDC for Myalept (metreleptin), Metreleptin 11.3 mg/2.2mL injection, powder, lyophilized, for solution, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Myalept (Metreleptin).
What is the active ingredient?: Metreleptin.
Who is the labeler?: Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Myalept?: 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.

Myalept (Metreleptin) NDC 10122-210