Prescription drug · ANDA
levocetirizine dihydrochloride NDC 63187-663
Levocetirizine dihydrochloride 5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-663-30 | 6318706633063187066330 | 30 TABLET in 1 BOTTLE (63187-663-30)Marketed from Mar 1, 2016 | |
| 63187-663-60 | 6318706636063187066360 | 60 TABLET in 1 BOTTLE (63187-663-60)Marketed from Mar 1, 2016 | |
| 63187-663-90 | 6318706639063187066390 | 90 TABLET in 1 BOTTLE (63187-663-90)Marketed from Mar 1, 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)
- levocetirizine dihydrochloride
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203646
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63187-663_9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7fSPL ID 9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7fSPL set ID b84ccb27-9c52-43b9-9a46-8f52a571045eRxCUI 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
N463187066330followed by a unit qualifier and the quantityPackage 63187-0663-30. 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)
Levocetirizine dihydrochloride tablets are a histamine H 1 ‑receptor antagonist indicated for: • The relief of symptoms associated with seasonal and perennial allergic rhinitis ( 1.1 , 1.2 ) • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. 1.2 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. 1.3 …
Excerpt only. Read the full label for complete information.
About NDC 63187-663
- What is NDC 63187-663?
- 63187-663 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- levocetirizine dihydrochloride.
- What is the active ingredient?
- Levocetirizine dihydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for levocetirizine dihydrochloride?
- 57 other product NDCs are listed under this name. See all levocetirizine dihydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other levocetirizine dihydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-206 | 85786-0206-30 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8810 | 68788-8810-0168788-8810-0368788-8810-06+1 more |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-148 | 51655-0148-52 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7934 | 68788-7934-0168788-7934-0368788-7934-06+1 more |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-564 | 51655-0564-52 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-152 | 85766-0152-35 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association INC | 63868-473 | 63868-0473-35 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | SAM'S WEST INC | 68196-406 | 68196-0406-20 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | BJWC (Berkley & Jensen / BJ'S) | 68391-955 | 68391-0955-11 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Rite Aid Corporation | 11822-5252 | 11822-5252-0111822-5252-07 |
Other NDCs under ANDA 203646
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 |
|---|---|---|---|---|
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8565 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Vensun Pharmaceuticals, Inc. | 42543-712 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-136 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-892 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-564 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8500 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2406 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7934 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-238 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Proficient Rx LP | 71205-476 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Proficient Rx LP | 71205-988 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0940 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1952 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2283 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1525 |