Fexofenadine HCl
- Product NDC
- 80513-506
- 11-digit product format
- 805130506
- Labeler code
- 80513
- Product ID
- 80513-506_21be7a92-2648-b2bf-e063-6394a90ac580
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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 |
|---|
| 80513-506-01 | Fexofenadine HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-506 | FEXOFENADINE HCL TABLET, FILM COATED [ADVANCED RX LLC] | 1 | Current NDC, 1 package rows | 20240912_c067b335-79c5-4176-a0b3-bae02a0c23f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80513-506-01 | 80513050601 | 100 TABLET, FILM COATED in 1 BOTTLE (80513-506-01) | 2024-09-10 | No | No | Current |