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NDC 51660-0998-55 FEXOFENADINE HYDROCHLORIDE 180 mg/1 Details
FEXOFENADINE HYDROCHLORIDE 180 mg/1
FEXOFENADINE HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by OHM LABORATORIES 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: 51660-0998-55Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 51660-0998 |
|---|---|
| Product ID | 51660-998_091c0633-b5d5-462a-8aa0-36ae245dbbbc |
| Associated GPIs | |
| 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 HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FEXOFENADINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 180 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | OHM LABORATORIES INC. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091567 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0998-55 (51660099855)
| NDC Package Code | 51660-998-55 |
|---|---|
| Billing NDC | 51660099855 |
| Package | 1 BOTTLE in 1 CARTON (51660-998-55) / 150 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2022-04-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1a1afa95-570d-456e-b436-a0fcfaf68517 Details
Uses
Warnings
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
When using this product
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton
†Compare To
the active ingredient of
Allegra® Allergy
NDC 51660-998-30
NDC 51660-998-55
NON-DROWSY
Fexofenadine Hydrochloride
Tablets, USP 180 mg
Antihistamine
Indoor and Outdoor Allergies
ALLERGY
24 Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
ohm®
30 Tablets
DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
"SEALED for YOUR PROTECTION" IS TORN OR MISSING
INGREDIENTS AND APPEARANCE
| FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coated |
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| Labeler - OHM LABORATORIES INC. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 650445203 | MANUFACTURE(51660-998) | |