Prescription drug · BLA
Xolair PFS (Omalizumab) NDC 50242-215
Omalizumab 150 mg/mL · Injection, Solution · Subcutaneous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-215-03 | 50242021503 | 1 SYRINGE, GLASS in 1 CARTON (50242-215-03) / 1 mL in 1 SYRINGE, GLASSMarketed from Aug 18, 2023 | |
| 50242-215-55 | 50242021555 | 1 SYRINGE, GLASS in 1 CARTON (50242-215-55) / 1 mL in 1 SYRINGE, GLASSMarketed from Aug 18, 2023 | |
| 50242-215-83 | 50242021583 | 1 SYRINGE, GLASS in 1 CARTON (50242-215-83) / 1 mL in 1 SYRINGE, GLASSMarketed from Aug 18, 2023 · Sample package | |
| 50242-215-99 | 50242021599 | 1 SYRINGE, GLASS in 1 CARTON (50242-215-99) / 1 mL in 1 SYRINGE, GLASSMarketed from Aug 18, 2023 · Sample package |
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)
- Xolair PFS
- Generic name (nonproprietary)
- omalizumab
- Active ingredients
- Omalizumab — 150 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103976
- Marketing start
- Listing expires
- Other FDA classes
- Decreased IgE Activity (Physiologic effect)IgE-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 50242-215_48785e56-4828-4f55-88e1-eca2cb88299dSPL ID 48785e56-4828-4f55-88e1-eca2cb88299dSPL set ID 7f6a2191-adfb-48b9-9bfa-0d9920479f0dRxCUI 1657209, 1657212, 2058943, 2058946, 2058949, 2058950, 2663917, 2663918, 2663920, 2663923, 2673760, 2673761, 2673762, 2673763UNII 2P471X1Z11
- 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
N450242021503followed by a unit qualifier and the quantityPackage 50242-0215-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods.…
Excerpt only. Read the full label for complete information.
About NDC 50242-215
- What is NDC 50242-215?
- 50242-215 is the product NDC for Xolair PFS (omalizumab), Omalizumab 150 mg/mL injection, solution, listed with the FDA by Genentech, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xolair PFS (Omalizumab).
- What is the active ingredient?
- Omalizumab.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xolair PFS?
- 1 other product NDC are listed under this name. See all Xolair PFS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xolair PFS products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xolair PFSomalizumab | Omalizumab 75 mg/.5mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-214 | 50242-0214-0350242-0214-5550242-0214-83+1 more |
Other NDCs under BLA 103976
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 |
|---|---|---|---|---|
| Xolairomalizumab | Omalizumab 150 mg/1.2mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-040 |
| Xolair PFSomalizumab | Omalizumab 75 mg/.5mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-214 |
| Xolairomalizumab | Omalizumab 300 mg/2mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-227 |