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 | 6811802001068118020010 | 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 | 6811802002568118020025 | 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.NDC labeler code 68118
- 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_5c140e17-d816-0b3e-e063-6294a90afc75SPL ID 5c140e17-d816-0b3e-e063-6294a90afc75
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68118-200
- What is NDC 68118-200?
- 68118-200 is the product NDC for Quzyttir (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/mL injection, listed with the FDA by ESTEVE PHARMACEUTICALS, S.A.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quzyttir (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- ESTEVE PHARMACEUTICALS, S.A., NDC labeler code 68118. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quzyttir?
- 1 other product NDC are listed under this name. See all Quzyttir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quzyttir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quzyttircetirizine hydrochloride | Cetirizine hydrochloride 10 mg/mL | InjectionIntravenous | TerSera Therapeutics LLC | 70720-100 | 70720-0100-1070720-0100-25 |
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 |