Over-the-counter drug · ANDA
Allergy Relief (Levocetirizine dihydrochloride usp, 5 mg) NDC 76162-915
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Coated · Oral · Topco Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-915-35 | 76162091535 | 1 BOTTLE in 1 CARTON (76162-915-35) / 35 TABLET, COATED in 1 BOTTLEMarketed from Sep 24, 2026 | |
| 76162-915-80 | 76162091580 | 1 BOTTLE in 1 CARTON (76162-915-80) / 80 TABLET, COATED in 1 BOTTLEMarketed from Sep 24, 2026 |
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)
- Allergy Relief
- Generic name (nonproprietary)
- levocetirizine dihydrochloride usp, 5 mg
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Topco Associates, LLCNDC labeler code 76162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213513
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-915_5c5224ad-696b-9fa8-e063-6394a90a7770SPL ID 5c5224ad-696b-9fa8-e063-6394a90a7770
- 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
N476162091535followed by a unit qualifier and the quantityPackage 76162-0915-35. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 76162-915
- What is NDC 76162-915?
- 76162-915 is the product NDC for Allergy Relief, Levocetirizine dihydrochloride 5 mg/1 tablet, coated, 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?
- Allergy Relief (Levocetirizine Dihydrochloride USP, 5 mg).
- What is the active ingredient?
- Levocetirizine dihydrochloride.
- Who is the labeler?
- Topco Associates, LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allergy Relief?
- 263 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 | 59726-0203-3859726-0203-54 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 | 46122-0829-51 |
Other NDCs under ANDA 213513
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 | TabletOral | YYBA CORP | 73581-201 |
| Allery Relief 24HR | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-451 |
| Curist Allergy Relieflevocetirizine dihydrochloride 5 mg | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Little Pharma, Inc. | 72559-021 |
| Goodmeds Levocetirizine Dihydrochloride 5mg 365 countlevocetirizine dihydrochloride 5mg | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4051 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-152 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-206 |