Fexofenadine HCL
- Product NDC
- 71205-531
- 11-digit product format
- 712050531
- Labeler code
- 71205
- Product ID
- 71205-531_db8ffe8f-d7f1-48f5-8ed2-9acca4e27884
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 |
|---|
| 71205-531-10 | Fexofenadine HCL | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 71205-531-15 | Fexofenadine HCL | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
| 71205-531-20 | Fexofenadine HCL | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 71205-531-30 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71205-531-60 | Fexofenadine HCL | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 71205-531-90 | Fexofenadine HCL | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-531 | FEXOFENADINE HCL TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 6 package rows | 20240316_f9a7e836-6055-484f-a197-181220428574.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 |
|---|
| 71205-531-10 | 71205053110 | 10 TABLET in 1 BOTTLE (71205-531-10) | 10 tablet | 2024-03-11 | | No | No | Current |
| 71205-531-15 | 71205053115 | 15 TABLET in 1 BOTTLE (71205-531-15) | 15 tablet | 2024-03-11 | | No | No | Current |
| 71205-531-20 | 71205053120 | 20 TABLET in 1 BOTTLE (71205-531-20) | 20 tablet | 2024-03-11 | | No | No | Current |
| 71205-531-30 | 71205053130 | 30 TABLET in 1 BOTTLE (71205-531-30) | 30 tablet | 2021-02-03 | 0000-00-00 | No | No | Current |
| 71205-531-60 | 71205053160 | 60 TABLET in 1 BOTTLE (71205-531-60) | 60 tablet | 2021-02-03 | 0000-00-00 | No | No | Current |
| 71205-531-90 | 71205053190 | 90 TABLET in 1 BOTTLE (71205-531-90) | 90 tablet | 2021-02-03 | 0000-00-00 | No | No | Current |