Fexofenadine Hydrochloride
- Product NDC
- 43598-936
- 11-digit product format
- 435980936
- Labeler code
- 43598
- Product ID
- 43598-936_67592c0a-bfc4-9a83-0e70-b12b4b3cea84
- 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
- 2020-12-01
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-936-01 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 43598-936-01 | Fexofenadine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 43598-936-30 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 43598-936-30 | Fexofenadine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-936 | FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250504_b0121213-eae1-8429-9986-3b3b26f35e47.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 |
|---|
| 43598-936-01 | 43598093601 | 1 BOTTLE in 1 CARTON (43598-936-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2020-12-01 | 0000-00-00 | No | No | Current |
| 43598-936-30 | 43598093630 | 1 BOTTLE in 1 CARTON (43598-936-30) > 30 TABLET in 1 BOTTLE | 1 bottle | 2020-12-01 | 0000-00-00 | No | No | Current |