Over-the-counter drug · ANDA
Childrens Cetirizine Hydrochloride Hives Relief (Cetirizine hydrochloride) NDC 58602-036
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-036-15 | 5860200361558602003615 | 1 BOTTLE in 1 CARTON (58602-036-15) / 120 mL in 1 BOTTLEMarketed from Feb 2, 2010 | |
| 58602-036-16 | 5860200361658602003616 | 1 BOTTLE in 1 CARTON (58602-036-16) / 240 mL in 1 BOTTLEMarketed from Feb 2, 2010 | |
| 58602-036-17 | 5860200361758602003617 | 480 mL in 1 BOTTLE (58602-036-17)Marketed 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 Cetirizine Hydrochloride Hives Relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- 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 58602-036_817c4587-fbf7-4763-b1b7-40f816092876SPL ID 817c4587-fbf7-4763-b1b7-40f816092876
- 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
N458602003615followed by a unit qualifier and the quantityPackage 58602-0036-15. 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 58602-036
- What is NDC 58602-036?
- 58602-036 is the product NDC for Childrens Cetirizine Hydrochloride Hives Relief, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Aurohealth LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Cetirizine Hydrochloride Hives Relief (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Cetirizine Hydrochloride Hives Relief?
- 1 other product NDC are listed under this name. See all Childrens Cetirizine Hydrochloride Hives Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Cetirizine Hydrochloride Hives Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-030 | 58602-0030-2058602-0030-2458602-0030-26 |
Other NDCs under ANDA 090750
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 |
|---|---|---|---|---|
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Fred's, Inc. | 55315-354 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-422 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | C.D.M.A., Inc. | 63868-865 |
| Childrens Cetirizine Hydrochloride Allergycetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-028 |
| Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-030 |