Prescription drug · BLA
Omlyclo (Omalizumab-igec) NDC 72606-035
Omalizumab 75 mg/.5mL · Injection · Subcutaneous · CELLTRION USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72606-035-01 | 7260600350172606003501 | 1 SYRINGE, GLASS in 1 CARTON (72606-035-01) / .5 mL in 1 SYRINGE, GLASSMarketed from Oct 5, 2026 |
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)
- Omlyclo
- Generic name (nonproprietary)
- omalizumab-igec
- Active ingredients
- Omalizumab — 75 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- CELLTRION USA, Inc.NDC labeler code 72606
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761399
- Marketing start
- Listing expires
- Other FDA classes
- Decreased IgE Activity (Physiologic effect)IgE-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 72606-035_0cfb7a85-6b8a-4530-aa3f-5a6aa7422d73SPL ID 0cfb7a85-6b8a-4530-aa3f-5a6aa7422d73
- Pharmacologic class
- Anti-IgE
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.
- NDC on a medical claim
N472606003501followed by a unit qualifier and the quantityPackage 72606-0035-01. 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 72606-035
- What is NDC 72606-035?
- 72606-035 is the product NDC for Omlyclo (omalizumab-igec), Omalizumab 75 mg/.5mL injection, listed with the FDA by CELLTRION USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omlyclo (Omalizumab-igec).
- What is the active ingredient?
- Omalizumab.
- Who is the labeler?
- CELLTRION USA, Inc., NDC labeler code 72606. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omlyclo?
- 2 other product NDCs are listed under this name. See all Omlyclo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omlyclo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omlycloomalizumab-igec | Omalizumab 150 mg/mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-036 | 72606-0036-01 |
| Omlycloomalizumab-igec | Omalizumab 300 mg/2mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-054 | 72606-0054-0172606-0054-02 |
Other NDCs under BLA 761399
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omlycloomalizumab-igec | Omalizumab 150 mg/mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-036 |
| Omlycloomalizumab-igec | Omalizumab 300 mg/2mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-054 |