Over-the-counter drug · ANDA
Topcare All Day Allergy (Levocetirizine dihydrochloride) NDC 36800-241
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-241-01 | 36800024101 | 1 BOTTLE in 1 CARTON (36800-241-01) / 35 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 5, 2020 | |
| 36800-241-46 | 36800024146 | 10 BLISTER PACK in 1 CARTON (36800-241-46) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 9, 2020 | |
| 36800-241-95 | 36800024195 | 1 BOTTLE in 1 CARTON (36800-241-95) / 45 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 7, 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)
- Topcare All Day Allergy
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- 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 211983
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-241_e685d7d8-ba5f-424a-9a98-54bde72bfacfSPL ID e685d7d8-ba5f-424a-9a98-54bde72bfacfSPL set ID 393616df-52f1-4e77-b69c-8239ca193d5bRxCUI 855172UNII SOD6A38AGA
- 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
N436800024101followed by a unit qualifier and the quantityPackage 36800-0241-01. 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 respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 36800-241
- What is NDC 36800-241?
- 36800-241 is the product NDC for Topcare All Day Allergy (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare All Day Allergy (Levocetirizine dihydrochloride).
- What is the active ingredient?
- Levocetirizine dihydrochloride.
- 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 All Day Allergy?
- 2 other product NDCs are listed under this name. See all Topcare 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 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 all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 36800-448 | 36800-0448-0936800-0448-4936800-0448-63 |
| TopCare All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-458 | 36800-0458-3936800-0458-4736800-0458-66+4 more |
Other NDCs under ANDA 211983
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 relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-3901 |
| allergy relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0241 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-488 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 |
| basic care allergy relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-241 |
| DG Health Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-241 |
| good sense levocetirizinelevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0241 |