topcare fexofenadine hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Fexofenadine Hydrochloride.
| Product ID | 36800-571_099f03b7-7d74-4bfa-b11e-78b475f07358 |
| NDC | 36800-571 |
| Product Type | Human Otc Drug |
| Proprietary Name | topcare fexofenadine hydrochloride |
| Generic Name | Fexofenadine Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-04-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076447 |
| Labeler Name | Topco Associates LLC |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Active Ingredient Strength | 180 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2011-04-14 |
| Marketing End Date | 2021-02-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-10-19 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-02-17 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-06-20 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-05-04 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-09-09 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-10-16 |
| Marketing End Date | 2015-01-03 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-14 |
| Marketing Category | ANDA |
| Application Number | ANDA076447 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-04-14 |
| Marketing End Date | 2011-04-14 |
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
| SPL SET ID: | b5ce2019-dcdc-4b82-9ae1-f2298ab2ea97 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36800-571 | topcare fexofenadine hydrochloride | topcare fexofenadine hydrochloride |
| 36800-425 | Topcare fexofenadine hydrochloride | Topcare fexofenadine hydrochloride |
| 10202-107 | Allergy | Fexofenadine hydrochloride |
| 11822-0425 | allergy relief | fexofenadine hydrochloride |
| 11822-0571 | allergy relief | fexofenadine hydrochloride |
| 11822-3698 | Allergy Relief | Fexofenadine hydrochloride |
| 21130-784 | Allergy Relief | Fexofenadine hydrochloride |
| 0363-0095 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 0363-0097 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 0363-0783 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 0363-9898 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0615-5619 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0615-5620 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0615-7636 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0904-5961 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0904-5962 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0904-5963 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 0904-6214 | fexofenadine hydrochloride | fexofenadine hydrochloride |
| 0904-6711 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 10202-229 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 13107-066 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 13107-067 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 21695-461 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 21695-462 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride |
| 30142-878 | Fexofenadine hydrochloride | Fexofenadine hydrochloride |
| 0179-8325 | Fexofenadine Hydrochloride 180 | Fexofenadine Hydrochloride |
| 0113-0571 | good sense aller ease | fexofenadine hydrochloride |
| 0113-0847 | good sense aller ease | fexofenadine hydrochloride |
| 11673-571 | up and up allergy relief | fexofenadine hydrochloride |
| 11673-617 | up and up allergy relief | fexofenadine hydrochloride |
| 11673-800 | up and up allergy relief | Fexofenadine Hydrochloride |
| 0363-0571 | wal fex allergy | fexofenadine hydrochloride |
| 0363-0784 | Wal-Fex | Fexofenadine hydrochloride |