Over-the-counter drug · ANDA
childrens allergy relief (Cetirizine hydrochloride) NDC 0363-3311
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-3311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-3311Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-3311-26 | 0036333112600363331126 | 1 BOTTLE in 1 CARTON (0363-3311-26) / 120 mL in 1 BOTTLEMarketed from Aug 5, 2022 | |
| 0363-3311-34 | 0036333113400363331134 | 1 BOTTLE in 1 CARTON (0363-3311-34) / 240 mL in 1 BOTTLEMarketed from Aug 5, 2022 |
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 allergy relief
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204226
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-3311_1d57d104-36ee-4210-ac65-4828d19ccab9SPL ID 1d57d104-36ee-4210-ac65-4828d19ccab9SPL set ID 2a62f905-663f-4aae-991f-a368b5120f6fRxCUI 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
N400363331126followed by a unit qualifier and the quantityPackage 00363-3311-26. 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 0363-3311
- What is NDC 0363-3311?
- 0363-3311 is the product NDC for childrens allergy relief (cetirizine hydrochloride), Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- childrens allergy relief (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Walgreen Company, 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 allergy relief?
- 43 other product NDCs are listed under this name. See all childrens allergy 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 allergy 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 allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-533 | 72288-0533-34 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | WALMART INC. | 79903-411 | 79903-0411-0479903-0411-08 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-818 | 51316-0818-08 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-611 | 51316-0611-34 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Safeway | 21130-607 | 21130-0607-08 |
| Childrens Allergy Relief | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Allegiant Health | 69168-471 | 69168-0471-59 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine HCl 12.5 mg/5mL | SolutionOral | Best Choice | 63941-505 | 63941-0505-26 |
| Childrens Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Cardinal Health 110, LLC. DBA Leader | 70000-0701 | 70000-0701-01 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Safeway | 21130-465 | 21130-0465-34 |
| Childrens Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-4023 | 00363-4023-08 |
Other NDCs under ANDA 204226
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 |
|---|---|---|---|---|
| allergy relief childrenscetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-837 |
| Basic Care Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-330 |
| basic care childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-475 |
| careone childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | American Sales Company | 41520-301 |
| careone childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | American Sales Company | 41520-902 |
| Childrens 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Meijer Distribution Inc | 41250-189 |
| Childrens 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Meijer Distribution Inc | 41250-475 |
| childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-189 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-475 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | HyVee Inc | 42507-203 |
| childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | HyVee Inc | 42507-475 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-818 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-982 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Walgreen Company | 0363-3393 |
| childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-0475 |
| childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-1189 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Safeway | 21130-465 |
| childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Safeway | 21130-653 |
| Childrens Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-509 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6765 |
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