Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 51672-2106
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2106-1 | 5167221060151672210601 | 1 BOTTLE in 1 CARTON (51672-2106-1) / 240 mL in 1 BOTTLEMarketed from May 20, 2011 | |
| 51672-2106-4 | 5167221060451672210604 | 1 BOTTLE in 1 CARTON (51672-2106-4) / 60 mL in 1 BOTTLEMarketed from May 20, 2011 | |
| 51672-2106-8 | 5167221060851672210608 | 1 BOTTLE in 1 CARTON (51672-2106-8) / 120 mL in 1 BOTTLEMarketed from May 20, 2011 |
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)
- Cetirizine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201546
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51672-2106_5698bba4-d090-a558-e063-6294a90a600aSPL ID 5698bba4-d090-a558-e063-6294a90a600aSPL set ID 67207357-5f8a-4424-9901-d2717a43cf1bRxCUI 1014673UNII 64O047KTOA
- 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
N451672210601followed by a unit qualifier and the quantityPackage 51672-2106-01. 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)
Uses temporarily relieves these symptoms due to hay fever or other upper 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 51672-2106
- What is NDC 51672-2106?
- 51672-2106 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride.
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetirizine Hydrochloride?
- 104 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-352 | 81469-0352-01 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 | 81469-0353-0181469-0353-0381469-0353-05+1 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-017 | 48433-0017-20 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Advagen Pharma Ltd., | 72888-480 | 72888-0480-01 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4072 | 68788-4072-0368788-4072-0668788-4072-09 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Bionpharma Inc. | 69452-426 | 69452-0426-5569452-0426-88 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-357 | 57237-0357-1257237-0357-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-358 | 57237-0358-1257237-0358-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-2261037-0480-2361037-0480-24+2 more |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 | 80513-0731-0580513-0731-12 |
Other NDCs under ANDA 201546
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 |
|---|---|---|---|---|
| All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-101 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | H E B | 37808-106 |
| Childrens Allergycetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Publix Super Markets Inc | 56062-106 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-106 |
| Childrens Cetirzinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Pharmacy Value Alliance LLC | 68016-106 |
| Rite Aid childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rite Aid Corporation | 11822-2106 |
| Wal-Zyr All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | WALGREEN COMPANY | 0363-2106 |