Fexofenadine HCL
- Product NDC
- 71335-1217
- 11-digit product format
- 713351217
- Labeler code
- 71335
- Product ID
- 71335-1217_7921f011-b1c5-4bf9-977c-dea10b285be0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204097
- Marketing category
- ANDA
- Marketing start
- 2016-08-19
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine HCL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997420 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1217-1 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71335-1217-2 | Fexofenadine HCL | 15 in 1 BOTTLE | TABLET | 15 | | 2 |
| 71335-1217-3 | Fexofenadine HCL | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71335-1217-4 | Fexofenadine HCL | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 71335-1217-5 | Fexofenadine HCL | 5 in 1 BOTTLE | TABLET | 5 | | 2 |
| 71335-1217-6 | Fexofenadine HCL | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
| 71335-1217-7 | Fexofenadine HCL | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1217 | FEXOFENADINE HCL TABLET [BRYANT RANCH PREPACK] | 2 | Current NDC, Legacy NDC, 7 package rows | 20240824_6bc92969-0d06-4bf5-a634-80964464546c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1217-1 | 71335121701 | 30 TABLET in 1 BOTTLE (71335-1217-1) | 30 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-2 | 71335121702 | 15 TABLET in 1 BOTTLE (71335-1217-2) | 15 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-3 | 71335121703 | 60 TABLET in 1 BOTTLE (71335-1217-3) | 60 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-4 | 71335121704 | 90 TABLET in 1 BOTTLE (71335-1217-4) | 90 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-5 | 71335121705 | 5 TABLET in 1 BOTTLE (71335-1217-5) | 5 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-6 | 71335121706 | 180 TABLET in 1 BOTTLE (71335-1217-6) | 180 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |
| 71335-1217-7 | 71335121707 | 100 TABLET in 1 BOTTLE (71335-1217-7) | 100 tablet | 2019-05-14 | 0000-00-00 | No | No | Current |