Over-the-counter drug · ANDA
Cetirizine hydrochloride NDC 50090-6538
Cetirizine hydrochloride 10 mg/1 · Tablet, Coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50090-6538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6538Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6538-1 | 5009065380150090653801 | 30 TABLET, COATED in 1 BOTTLE (50090-6538-1)Marketed from Jul 4, 2023 | |
| 50090-6538-3 | 5009065380350090653803 | 90 TABLET, COATED in 1 BOTTLE (50090-6538-3)Marketed from Jul 5, 2023 |
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 — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-6538_b6221e59-ed88-4d25-a948-0f90c16f8dcfSPL ID b6221e59-ed88-4d25-a948-0f90c16f8dcfSPL set ID f4da9adf-840d-4526-86a6-6666183fd107RxCUI 1014678UNII 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
N450090653801followed by a unit qualifier and the quantityPackage 50090-6538-01. 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)
USE(S) 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 50090-6538
- What is NDC 50090-6538?
- 50090-6538 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by A-S Medication Solutions. It has 2 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?
- A-S Medication Solutions, NDC labeler code 50090. 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?
- 107 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 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-0261037-0480-0361037-0480-04+2 more |
Other NDCs under ANDA 209274
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 |
|---|---|---|---|---|
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc | 85828-194 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | AAA PHARMACEUTICAL, INC. | 57344-194 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bi-Mar | 37835-611 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-0057 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | LIDL US LLC | 71141-294 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-091 |
| Cetirizinecetiirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-764 |
| Crcle Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-250 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules Pharmaceuticals Inc. | 70010-163 |
| ValuMeds 24-Hour Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1003 |
| CABINET Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0119 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9733 |
| ValuMeds Cetirizine 10mgcetirizine 10mg | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health | 82725-1203 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-806 |
| Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | YYBA CORP | 73581-202 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules India Ltd | 62207-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4230 |
| Allergy Relief | Cetirizine hydrochloride 10 mg/1 | TabletOral | Demoulas Super Markets, Inc. | 53942-396 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4219 |
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