What is NDC 69097-664?

69097-664 is the product NDC for Icatibant, Icatibant acetate 30 mg/3mL injection, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-664 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-664Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0664Add 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
69097-664-34	6909706643469097066434	1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASSMarketed from Jul 13, 2020
69097-664-68	6909706646869097066468	3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 3 mL in 1 SYRINGE, GLASSMarketed from Jul 13, 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 — 30 mg/3mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212446
Marketing start: Jul 13, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Bradykinin B2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69097-664_430ca904-a971-4233-a98b-46ca19275dabSPL ID 430ca904-a971-4233-a98b-46ca19275dabSPL set ID ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6RxCUI 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

N469097066434 followed by a unit qualifier and the quantity

Package 69097-0664-34. 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 Feb 16, 2024.

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 69097-664

What is NDC 69097-664?: 69097-664 is the product NDC for Icatibant, Icatibant acetate 30 mg/3mL injection, listed with the FDA by Cipla USA Inc.. 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?: Cipla USA Inc., NDC labeler code 69097. 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 10 mg/mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	63323-574	63323-0574-8663323-0574-93
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

Other NDCs under ANDA 212446

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

FDA NDC Directory listings under ANDA 212446
Product	Strength	Form · route	Labeler	Product NDC
Sajaziricatibant	Icatibant acetate 30 mg/3mL	InjectionSubcutaneous	Cycle Pharmaceuticals Ltd-Uk	70709-013