Fexofenadine Hydrochloride
- Product NDC
- 71309-091
- 11-digit product format
- 713090091
- Labeler code
- 71309
- Product ID
- 71309-091_f7f18cee-5649-13c4-e053-6294a90ad4a8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safrel Pharmaceuticals, LLC.
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2021-01-03
- 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 Hydrochloride
- 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 |
|---|
| 71309-091-01 | Fexofenadine Hydrochloride | 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 |
|---|
| 71309-091 | FEXOFENADINE HYDROCHLORIDE TABLET [SAFREL PHARMACEUTICALS, LLC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230329_d6120f56-ab28-2696-e053-2995a90adf47.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 |
|---|
| 71309-091-01 | 71309009101 | 100 TABLET in 1 BOTTLE (71309-091-01) | 100 tablet | 2021-01-31 | 0000-00-00 | No | No | Current |