Over-the-counter drug · ANDA
Childrens Allergy Relief (cetirizine hydrochloride) NDC 63868-865
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · C.D.M.A., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-865-04 | 63868086504 | 1 BOTTLE in 1 CARTON (63868-865-04) / 120 mL in 1 BOTTLEMarketed from Nov 20, 2014 |
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
- C.D.M.A., Inc.
- 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 63868-865_434f1b5b-1e26-406a-a5e2-df310b74e993SPL ID 434f1b5b-1e26-406a-a5e2-df310b74e993SPL set ID b4feed95-86ca-411c-99b5-773e485e752fRxCUI 1014673UNII 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
N463868086504followed by a unit qualifier and the quantityPackage 63868-0865-04. 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 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 Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-036 |
| 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 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Aurohealth LLC | 58602-422 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Fred's, Inc. | 55315-354 |