Prescription drug · ANDA
levocetirizine dihydrochloride NDC 55111-282
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Coated · Oral · Dr.Reddy's laboratories Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-282-01 | 55111028201 | 100 TABLET, COATED in 1 BOTTLE (55111-282-01)Marketed from Feb 24, 2011 | |
| 55111-282-05 | 55111028205 | 500 TABLET, COATED in 1 BOTTLE (55111-282-05)Marketed from Feb 24, 2011 | |
| 55111-282-18 | 55111028218 | 180 TABLET, COATED in 1 BOTTLE (55111-282-18)Marketed from Feb 24, 2011 | |
| 55111-282-30 | 55111028230 | 30 TABLET, COATED in 1 BOTTLE (55111-282-30)Marketed from Feb 24, 2011 | |
| 55111-282-60 | 55111028260 | 60 TABLET, COATED in 1 BOTTLE (55111-282-60)Marketed from Feb 24, 2011 | |
| 55111-282-78 | 55111028278 | 10 BLISTER PACK in 1 CARTON (55111-282-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79)Marketed from Feb 24, 2011 | |
| 55111-282-90 | 55111028290 | 90 TABLET, COATED in 1 BOTTLE (55111-282-90)Marketed from Feb 24, 2011 |
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, Coated
- Route
- Oral
- Labeler
- Dr.Reddy's laboratories Ltd.NDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090392
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-282_acb3404e-c2a4-f21f-5f5b-f0ceab355395SPL ID acb3404e-c2a4-f21f-5f5b-f0ceab355395SPL set ID c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4aRxCUI 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
N455111028201followed by a unit qualifier and the quantityPackage 55111-0282-01. 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)
Levocetirizine dihydrochloride is 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 2 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 months of age and older. 1.3 Chronic Idiopa…
Excerpt only. Read the full label for complete information.
About NDC 55111-282
- What is NDC 55111-282?
- 55111-282 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, coated, listed with the FDA by Dr.Reddy's laboratories Ltd.. It has 7 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?
- Dr.Reddy's laboratories Ltd., NDC labeler code 55111. 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 |