What is NDC 70709-013?

70709-013 is the product NDC for Sajazir (icatibant), Icatibant acetate 30 mg/3mL injection, listed with the FDA by Cycle Pharmaceuticals Ltd-Uk. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cycle Pharmaceuticals Ltd-Uk, 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 Sajazir?

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.

Sajazir NDC 70709-013 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70709-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70709-0013Add 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
70709-013-01	7070900130170709001301	1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASSMarketed from Jun 3, 2021
70709-013-03	7070900130370709001303	3 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASSMarketed from Jun 3, 2021

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): Sajazir
Generic name (nonproprietary): icatibant
Active ingredients: Icatibant acetate — 30 mg/3mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Cycle Pharmaceuticals Ltd-UkNDC labeler code 70709
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212446
Marketing start: Jun 3, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Bradykinin B2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1SPL ID 98f58ca8-04a0-4453-adf0-b000d3bcfae1SPL set ID 1756aca0-21a1-4898-8d6c-9666738db45cRxCUI 1148141, 2569480UNII 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

N470709001301 followed by a unit qualifier and the quantity

Package 70709-0013-01. 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

Current FDA label (SPL), effective Feb 16, 2024.

Indications (excerpt from the label)

SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (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 70709-013

What is NDC 70709-013?: 70709-013 is the product NDC for Sajazir (icatibant), Icatibant acetate 30 mg/3mL injection, listed with the FDA by Cycle Pharmaceuticals Ltd-Uk. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sajazir (Icatibant).
What is the active ingredient?: Icatibant acetate.
Who is the labeler?: Cycle Pharmaceuticals Ltd-Uk, 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 Sajazir?: 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 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
Icatibant	Icatibant acetate 30 mg/3mL	InjectionSubcutaneous	Cipla USA Inc.	69097-664

Sajazir (Icatibant) NDC 70709-013