Over-the-counter drug · ANDA
Cetirizine hydrochloride NDC 70010-163
Cetirizine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-163-05 | 7001001630570010016305 | 500 TABLET, COATED in 1 BOTTLE (70010-163-05)Marketed from Jan 13, 2022 | |
| 70010-163-09 | 7001001630970010016309 | 90 TABLET, COATED in 1 BOTTLE (70010-163-09)Marketed from Apr 26, 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)
- Cetirizine hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- 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 70010-163_5d4ee37e-639d-588c-e063-6294a90a1801SPL ID 5d4ee37e-639d-588c-e063-6294a90a1801
- 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
N470010016305followed by a unit qualifier and the quantityPackage 70010-0163-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70010-163
- What is NDC 70010-163?
- 70010-163 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Granules Pharmaceuticals Inc.. 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?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. 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 |
| 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 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1047 |
Showing 20 of 39.