Fexofenadine HCl and Pseudoephedrine HCI is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride.
| Product ID | 55111-447_525f547d-5d98-ecff-8eb4-13ceb0407e4d |
| NDC | 55111-447 |
| Product Type | Human Otc Drug |
| Proprietary Name | Fexofenadine HCl and Pseudoephedrine HCI |
| Generic Name | Fexofenadine Hcl And Pseudoephedrine Hci |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-11-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076667 |
| Labeler Name | Dr. Reddy's Laboratories Limited |
| Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Active Ingredient Strength | 60 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2014-11-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076667 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-11-18 |
| Marketing Category | ANDA |
| Application Number | ANDA076667 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-08-07 |
| Marketing Category | ANDA |
| Application Number | ANDA076667 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-11-18 |
| Marketing Category | ANDA |
| Application Number | ANDA076667 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-11-18 |
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
| SPL SET ID: | 728632be-7e5c-2d06-4c95-bc8ecc9be2ec |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0363-0448 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 0363-1606 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 0536-1242 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 11673-032 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 21130-557 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 30142-447 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 30142-611 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 37808-022 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 43598-823 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 49035-273 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 55111-447 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 55111-557 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 59779-508 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 69842-249 | Fexofenadine HCl and Pseudoephedrine HCI | Fexofenadine HCl and Pseudoephedrine HCI |
| 70000-0518 | 12HR Allergy and Congestion Relief | Fexofenadine HCl and Pseudoephedrine HCI |
| 11822-7388 | Allergy and Congestion | Fexofenadine HCl and Pseudoephedrine HCI |
| 62011-0455 | Allergy and Congestion | Fexofenadine HCl and Pseudoephedrine HCI |