Over-the-counter drug · ANDA
allergy relief (levocetirizine dihydrochloride) NDC 0363-3901
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Film coated · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-3901-01 | 00363390101 | 1 BOTTLE in 1 CARTON (0363-3901-01) / 35 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 23, 2021 | |
| 0363-3901-27 | 00363390127 | 1 BOTTLE in 1 CARTON (0363-3901-27) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 23, 2021 | |
| 0363-3901-76 | 00363390176 | 1 BOTTLE in 1 CARTON (0363-3901-76) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 23, 2021 |
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)
- allergy relief
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Walgreen Company
- 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 0363-3901_9f9913a7-9054-4d73-b480-e9a5f6446373SPL ID 9f9913a7-9054-4d73-b480-e9a5f6446373SPL set ID 5033f8e3-c1c4-44e9-a774-703d9b04e82cRxCUI 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
N400363390101followed by a unit qualifier and the quantityPackage 00363-3901-01. 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.
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 |
|---|---|---|---|---|
| DG Health Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-241 |
| allergy relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0241 |
| good sense levocetirizinelevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0241 |
| 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 |
| Topcare All Day Allergylevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-241 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-488 |