Over-the-counter drug · ANDA
Childrens Cetirizine Hydrochloride NDC 58602-856
cetirizine hydrochloride · Cetirizine hydrochloride 10 mg/1 · Tablet, Orally disintegrating · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-856-14 | 58602085614 | 11 BLISTER PACK in 1 CARTON (58602-856-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 11, 2020 | |
| 58602-856-75 | 58602085675 | 2 BLISTER PACK in 1 CARTON (58602-856-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 11, 2020 | |
| 58602-856-76 | 58602085676 | 4 BLISTER PACK in 1 CARTON (58602-856-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 11, 2020 |
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
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213557
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-856_b304311b-7c20-4cfe-a42f-bbe033378811SPL ID b304311b-7c20-4cfe-a42f-bbe033378811SPL set ID cd895177-3c25-4a1b-81a0-b85f4877787aRxCUI 1011482UNII 64O047KTOA
- 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
N458602085614followed by a unit qualifier and the quantityPackage 58602-0856-14. 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)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213557
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 |
|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-860 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-862 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-0471 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-234 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | TOPCO ASSOCIATES LLC | 76162-009 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-4025 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | KROGER COMPANY | 30142-058 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-406 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-961 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-838 |