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NDC 72189-0305-30 Fexofenadine 180 mg/1 Details
Fexofenadine 180 mg/1
Fexofenadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRx. 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: 72189-0305-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 72189-0305 |
|---|---|
| Product ID | 72189-305_d35a5ce4-cd84-5b1f-e053-2995a90a24db |
| Associated GPIs | 41550024100350 |
| GCN Sequence Number | 033716 |
| GCN Sequence Number Description | fexofenadine HCl TABLET 180 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 46594 |
| HICL Sequence Number | 011595 |
| HICL Sequence Number Description | FEXOFENADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Fexofenadine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fexofenadine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 180 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | DirectRx |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204097 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0305-30 (72189030530)
| NDC Package Code | 72189-305-30 |
|---|---|
| Billing NDC | 72189030530 |
| Package | 30 TABLET in 1 BOTTLE (72189-305-30) |
| Marketing Start Date | 2021-12-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d35a5ce4-cd83-5b1f-e053-2995a90a24db Details
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60 mg
adults and children 12 years of age and over
take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor
180 mg
adults and children 12 years of age and over
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| FEXOFENADINE
fexofenadine tablet |
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| Labeler - DirectRx (079254320) |
| Registrant - DirectRx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DirectRx | 079254320 | repack(72189-305) | |