Over-the-counter drug · ANDA
TopCare Childrens All Day Allergy (Cetirizine hcl) NDC 36800-475
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-475-00 | 3680004750036800047500 | 1 BOTTLE in 1 CARTON (36800-475-00) / 240 mL in 1 BOTTLEMarketed from Nov 1, 2021 | |
| 36800-475-26 | 3680004752636800047526 | 1 BOTTLE in 1 CARTON (36800-475-26) / 118 mL in 1 BOTTLEMarketed from Feb 2, 2016 |
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)
- TopCare Childrens All Day Allergy
- Generic name (nonproprietary)
- cetirizine hcl
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-475_11d505ff-696b-462c-8952-0c73491de9f4SPL ID 11d505ff-696b-462c-8952-0c73491de9f4SPL set ID 48555c1f-8c2a-4ab2-9af3-d2488ca509e4RxCUI 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
N436800047500followed by a unit qualifier and the quantityPackage 36800-0475-00. 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 36800-475
- What is NDC 36800-475?
- 36800-475 is the product NDC for TopCare Childrens All Day Allergy, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Childrens All Day Allergy (Cetirizine HCl).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare Childrens All Day Allergy?
- 1 other product NDC are listed under this name. See all TopCare Childrens All Day Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TopCare Childrens All Day Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topcare Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-189 | 36800-0189-26 |
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 |
|---|---|---|---|---|
| Good Neighbor Pharmacy Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-203 |
| childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-189 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-7068 |
| 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 |
| Members Mark Childrens Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Sam's West Inc | 68196-475 |
| up and up childrens allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Target Corporation | 82442-475 |
| Basic Care Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-330 |
| Equaline childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-475 |
| Topcare Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-189 |
| Kirkland Signature Childrens Aller Teccetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Costco Wholesale Company | 63981-475 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-982 |
| Good Sense Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-0189 |
| foster and thrive childrens allergy reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 70677-1042 |
| Childrens 24 Hour Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Meijer Distribution Inc | 41250-475 |
| Childrens Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | CVS Pharmacy | 59779-509 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8188 |
| Childrens All Day Allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Kroger Company | 30142-475 |
| basic care childrens all day allergycetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-475 |
| Welby Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Aldi Inc | 64024-475 |
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