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NDC 58602-0426-20 Fexofenadine Hydrochloride 30 mg/5mL Details
Fexofenadine Hydrochloride 30 mg/5mL
Fexofenadine Hydrochloride is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is FEXOFENADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.
Related Packages: 58602-0426-20Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 58602-0426 |
|---|---|
| Product ID | 58602-426_a75ff860-f7e0-4e19-846b-fbe33e0e1dfd |
| 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 | Fexofenadine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fexofenadine Hydrochloride Oral |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/5mL |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | Aurohealth LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213466 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58602-0426-20 (58602042620)
| NDC Package Code | 58602-426-20 |
|---|---|
| Billing NDC | 58602042620 |
| Package | 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE |
| Marketing Start Date | 2023-05-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |