What is NDC 63323-574?

63323-574 is the product NDC for Icatibant, Icatibant acetate 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Icatibant?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Icatibant NDC 63323-574 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-574Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0574Add 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
63323-574-86	6332305748663323057486	1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)Marketed from Nov 15, 2020
63323-574-93	6332305749363323057493	3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGEMarketed from Nov 15, 2020

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): Icatibant
Generic name (nonproprietary): icatibant
Active ingredients: Icatibant acetate — 10 mg/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208317
Marketing start: Nov 15, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Bradykinin B2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210cSPL ID d1c9afa7-c4ac-4739-85f1-2ae82440210cSPL set ID 52c12c15-c00b-4efc-952d-1425c907706aRxCUI 1148141UNII 325O8467XK
Pharmacologic class: Bradykinin B2 Receptor Antagonist

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

N463323057486 followed by a unit qualifier and the quantity

Package 63323-0574-86. 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 Nov 8, 2023.

Indications (excerpt from the label)

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-574

What is NDC 63323-574?: 63323-574 is the product NDC for Icatibant, Icatibant acetate 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Icatibant.
What is the active ingredient?: Icatibant acetate.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Icatibant?: 6 other product NDCs are listed under this name. See all Icatibant NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Icatibant NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Icatibant	Icatibant acetate 30 mg/3mL	InjectionSubcutaneous	Alembic Pharmaceuticals Limited	46708-654	46708-0654-0346708-0654-09
Icatibant	Icatibant acetate 30 mg/3mL	InjectionSubcutaneous	Alembic Pharmaceuticals Inc.	62332-654	62332-0654-0362332-0654-09
Icatibant	Icatibant acetate 30 mg/3mL	Injection, SolutionSubcutaneous	Eugia US LLC	55150-351	55150-0351-0155150-0351-03
Icatibant	Icatibant acetate 30 mg/3mL	InjectionSubcutaneous	Cipla USA Inc.	69097-664	69097-0664-3469097-0664-68
Icatibant	Icatibant acetate 30 mg/3mL	Injection, SolutionSubcutaneous	Hikma Pharmaceuticals USA Inc.	24201-207	24201-0207-0124201-0207-03
Icatibant	Icatibant acetate 10 mg/mL	Injection, SolutionSubcutaneous	Teva Pharmaceuticals USA, Inc.	0093-3066	00093-3066-3400093-3066-93