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NDC 65162-0045-03 Cetirizine Hydrochloride 5 mg/1 Details
Cetirizine Hydrochloride 5 mg/1
Cetirizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. 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: 65162-0045-03Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Cetirizine
Cetirizine injection is used to treat acute urticaria in adults and children 6 months of age or older. 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.
Related Packages: 65162-0045-03Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Cetirizine Injection
Product Information
| NDC | 65162-0045 |
|---|---|
| Product ID | 65162-045_785feb22-255b-47c0-91eb-2915f55cac9e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078780 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0045-03 (65162004503)
| NDC Package Code | 65162-045-03 |
|---|---|
| Billing NDC | 65162004503 |
| Package | 1 BOTTLE in 1 CARTON (65162-045-03) / 30 TABLET in 1 BOTTLE |
| Marketing Start Date | 2010-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |