Fexofenadine hydrochloride
- Product NDC
- 43598-809
- 11-digit product format
- 435980809
- Labeler code
- 43598
- Product ID
- 43598-809_b7a3db43-ce44-e0e8-a3a3-b9412da4de27
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2018-12-26
- 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 |
|---|
| 43598-809-18 | Fexofenadine hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 43598-809-18 | Fexofenadine hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 3 |
| 43598-809-90 | Fexofenadine hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 43598-809-90 | Fexofenadine hydrochloride | 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 |
|---|
| 43598-809 | FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241114_624b3a91-af4f-8848-6fc3-392e0df34cc8.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 |
|---|
| 43598-809-18 | 43598080918 | 1 BOTTLE in 1 CARTON (43598-809-18) / 180 TABLET in 1 BOTTLE | 1 bottle | 2018-12-26 | 0000-00-00 | No | No | Current |
| 43598-809-90 | 43598080990 | 1 BOTTLE in 1 CARTON (43598-809-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2018-12-26 | 0000-00-00 | No | No | Current |