Prescription drug · NDA
Quzyttir (cetirizine hydrochloride) NDC 68118-200
Cetirizine hydrochloride 10 mg/mL · Injection · Intravenous · ESTEVE PHARMACEUTICALS, S.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68118-200-10 | 68118020010 | 1 VIAL, GLASS in 1 CARTON (68118-200-10) / 1 mL in 1 VIAL, GLASS (68118-200-01)Marketed from Apr 2, 2020 | |
| 68118-200-25 | 68118020025 | 25 VIAL, GLASS in 1 CARTON (68118-200-25) / 1 mL in 1 VIAL, GLASS (68118-200-01)Marketed from Nov 13, 2019 |
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)
- Quzyttir
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- ESTEVE PHARMACEUTICALS, S.A.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211415
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68118-200_58f0707f-577d-c820-e063-6294a90ac2ceSPL ID 58f0707f-577d-c820-e063-6294a90ac2ceSPL set ID 573770f6-b76e-f6ba-e063-6294a90aa54dRxCUI 2261746, 2261754UNII 64O047KTOAUPC 0368118200102
- Pharmacologic class
- Histamine-1 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.
- NDC on a medical claim
N468118020010followed by a unit qualifier and the quantityPackage 68118-0200-10. 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 .
Indications (excerpt from the label)
QUZYTTIR ® is indicated for the treatment of acute urticaria in adults and children 6 months of age and older. QUZYTTIR ® is a histamine-1 (H 1 ) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older ( 1 ) Limitations of Use : Not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function ( 1 ) Limitations of use: QUZYTTIR ® is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211415
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 |
|---|---|---|---|---|
| Quzyttircetirizine hydrochloride | Cetirizine hydrochloride 10 mg/mL | InjectionIntravenous | TerSera Therapeutics LLC | 70720-100 |