Over-the-counter drug · ANDA
Childrens Allergy Relief (cetirizine hydrochloride) NDC 58602-422
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-422-12 | 58602042212 | 1 BOTTLE in 1 CARTON (58602-422-12) / 120 mL in 1 BOTTLEMarketed from Feb 2, 2010 | |
| 58602-422-17 | 58602042217 | 480 mL in 1 BOTTLE (58602-422-17)Marketed from Feb 2, 2010 | |
| 58602-422-20 | 58602042220 | 1 BOTTLE in 1 CARTON (58602-422-20) / 240 mL in 1 BOTTLEMarketed from Feb 2, 2010 |
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)
- Childrens Allergy Relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090750
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-422_4e1f7b3b-b650-4e2a-b431-1305c998c565SPL ID 4e1f7b3b-b650-4e2a-b431-1305c998c565
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458602042212followed by a unit qualifier and the quantityPackage 58602-0422-12. 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.