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NDC 50090-5510-03 Cetirizine 10 mg/1 Details
Cetirizine 10 mg/1
Cetirizine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is CETIRIZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 50090-5510-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 50090-5510 |
|---|---|
| Product ID | 50090-5510_7d4124eb-c5be-4a8b-90ea-0d02e1d841bc |
| Associated GPIs | |
| GCN Sequence Number | 017037 |
| GCN Sequence Number Description | cetirizine HCl TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49291 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cetirizine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | A-S Medication Solutions |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078336 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50090-5510-03 (50090551003)
| NDC Package Code | 50090-5510-3 |
|---|---|
| Billing NDC | 50090551003 |
| Package | 1 BOTTLE in 1 CARTON (50090-5510-3) / 90 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-04-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |