Search by Drug Name or NDC
NDC 71399-8659-01 fexofenadine hcl 60 mg/1 Details
fexofenadine hcl 60 mg/1
fexofenadine hcl is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by AKRON PHARMA INC. 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: 71399-8659-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 71399-8659 |
|---|---|
| Product ID | 71399-8659_27a5c104-a914-4bbc-82e1-53921ba5b19f |
| Associated GPIs | 41550024100320 |
| GCN Sequence Number | 031689 |
| GCN Sequence Number Description | fexofenadine HCl TABLET 60 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 46593 |
| HICL Sequence Number | 011595 |
| HICL Sequence Number Description | FEXOFENADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | fexofenadine hcl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fexofenadine hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | AKRON PHARMA INC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204507 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71399-8659-01 (71399865901)
| NDC Package Code | 71399-8659-1 |
|---|---|
| Billing NDC | 71399865901 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) |
| Marketing Start Date | 2021-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |