Fexofenadine HCL
- Product NDC
- 68788-7449
- 11-digit product format
- 687887449
- Labeler code
- 68788
- Product ID
- 68788-7449_73d293e2-385d-4dd7-a9de-fd112e8aa778
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine HCL
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-7449-1 | Fexofenadine HCL | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 68788-7449-3 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 68788-7449-6 | Fexofenadine HCL | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 68788-7449-9 | Fexofenadine HCL | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7449 | FEXOFENADINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250514_67679801-a8fe-4038-be71-96e1312badab.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 |
|---|
| 68788-7449-1 | 68788744901 | 100 TABLET in 1 BOTTLE (68788-7449-1) | 100 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7449-3 | 68788744903 | 30 TABLET in 1 BOTTLE (68788-7449-3) | 30 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7449-6 | 68788744906 | 60 TABLET in 1 BOTTLE (68788-7449-6) | 60 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7449-9 | 68788744909 | 90 TABLET in 1 BOTTLE (68788-7449-9) | 90 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |