Fexofenadine Hydrochloride
- Product NDC
- 45802-847
- 11-digit product format
- 458020847
- Labeler code
- 45802
- Product ID
- 45802-847_e43b561e-d68a-47af-be93-d710f0f77505
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA212971
- Marketing category
- ANDA
- Marketing start
- 2022-01-07
- 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 |
|---|
| 45802-847-78 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 45802-847-78 | Fexofenadine Hydrochloride | 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 |
|---|
| 45802-847 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220223_e43b561e-d68a-47af-be93-d710f0f77505.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 |
|---|
| 45802-847-78 | 45802084778 | 1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-01-07 | 0000-00-00 | No | No | Current |