Over-the-counter drug · ANDA
Childrens Cetirizine Hydrochloride (Cetirizine hydrochloride) NDC 0363-4025
Cetirizine hydrochloride 10 mg/1 · Tablet, Orally disintegrating · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-4025-76 | 0036340257600363402576 | 4 BLISTER PACK in 1 CARTON (0363-4025-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 11, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- WALGREEN CO.NDC labeler code 0363
- 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 0363-4025_ed5abf26-6de5-46f8-924a-744e4fc5a04eSPL ID ed5abf26-6de5-46f8-924a-744e4fc5a04eSPL set ID a9fd9b8f-509b-1ffa-e053-2a95a90a6d0fRxCUI 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
N400363402576followed by a unit qualifier and the quantityPackage 00363-4025-76. 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.
About NDC 0363-4025
- What is NDC 0363-4025?
- 0363-4025 is the product NDC for Childrens Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, orally disintegrating, listed with the FDA by WALGREEN CO.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Cetirizine Hydrochloride (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- WALGREEN CO., NDC labeler code 0363. 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?
- 9 other product NDCs are listed under this name. See all Childrens Cetirizine Hydrochloride 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 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 Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-406 | 79903-0406-10 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2147 | 51672-2147-0151672-2147-08 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8188 | 68788-8188-01 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-961 | 69842-0961-76 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-856 | 58602-0856-1458602-0856-7558602-0856-76 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6765 | 00904-6765-20 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6765 | 17856-6765-0117856-6765-0317856-6765-09 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Proficient Rx LP | 71205-722 | 71205-0722-04 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Chain Drug Consortium, LLC (Premier Value) | 68016-023 | 68016-0023-43 |
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 | WALGREEN CO. | 0363-0471 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | KROGER COMPANY | 30142-058 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-838 |
| 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 | 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 | Aurohealth LLC | 58602-856 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-961 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-406 |