Over-the-counter drug · ANDA
levocetirizine dihydrochloride NDC 37808-126
Levocetirizine dihydrochloride 5 mg/1 · Tablet, Coated · Oral · HEB
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-126-10 | 3780801261037808012610 | 2 BLISTER PACK in 1 BLISTER PACK (37808-126-10) / 5 TABLET, COATED in 1 BLISTER PACKMarketed from Jun 15, 2019 | |
| 37808-126-35 | 3780801263537808012635 | 1 BOTTLE in 1 BOTTLE (37808-126-35) / 35 TABLET, COATED in 1 BOTTLEMarketed from Jun 15, 2019 | |
| 37808-126-80 | 3780801268037808012680 | 1 BOTTLE in 1 CARTON (37808-126-80) / 80 TABLET, COATED in 1 BOTTLEMarketed from Oct 1, 2022 |
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
- HEBNDC labeler code 37808
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210375
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 37808-126_a08f35dd-f3d5-5689-c975-0ed213c90c7dSPL ID a08f35dd-f3d5-5689-c975-0ed213c90c7dSPL set ID b13ab6fc-4fec-c870-2c5f-b5e31dec722aRxCUI 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
N437808012610followed by a unit qualifier and the quantityPackage 37808-0126-10. 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 sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 37808-126
- What is NDC 37808-126?
- 37808-126 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, coated, listed with the FDA by HEB. 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?
- HEB, NDC labeler code 37808. 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?
- 59 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 | Camber Consumer Care Inc | 69230-321 | 69230-0321-0169230-0321-1069230-0321-31+3 more |
| 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 |
Other NDCs under ANDA 210375
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, CoatedOral | KROGER COMPANY | 30142-717 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association INC | 63868-473 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-938 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Inc. | 43598-735 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Inc. | 43598-810 |
| 24HR Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | LEADER/ Cardinal Health 110, Inc. | 70000-0362 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Walmart Inc. | 49035-492 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Target Corporation | 11673-847 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Walgreens Company | 0363-5529 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | CVS PHARMACY | 69842-761 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Rite Aid Corporation | 11822-5252 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | SAM'S WEST INC | 68196-406 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Albertsons Companies | 21130-732 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | BJWC (Berkley & Jensen / BJ'S) | 68391-955 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | AMERISOURCEBERGEN DRUG CORPORATION | 46122-531 |