Prescription drug · ANDA
Levocetirizine Dihydrochloride NDC 68071-3726
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3726-9 | 68071372609 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3726-9)Marketed from Nov 22, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090199
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68071-3726_27878da9-3e05-df72-e063-6394a90a378bSPL ID 27878da9-3e05-df72-e063-6394a90a378bSPL set ID 2787aaa2-5209-f7d5-e063-6294a90a7103RxCUI 855172UNII SOD6A38AGAUPC 0368071372694
- 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
N468071372609followed by a unit qualifier and the quantityPackage 68071-3726-09. 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 treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 68071-3726
- What is NDC 68071-3726?
- 68071-3726 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 090199
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 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7701 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-479 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-232 |