Fexofenadine HCL
- Product NDC
- 70010-183
- 11-digit product format
- 700100183
- Labeler code
- 70010
- Product ID
- 70010-183_451e21a2-6057-7a94-e063-6294a90a9f87
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GRANULES PHARMACEUTICALS INC.
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2023-04-25
- 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 HCL
- 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 |
|---|
| 70010-183-03 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-183 | FEXOFENADINE HCL TABLET [GRANULES PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20230428_fa30c8ce-ad9d-b6fe-e053-6294a90a2443.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70010-183-03 | 70010018303 | 30 TABLET in 1 BOTTLE (70010-183-03) | 30 tablet | 2023-04-25 | No | No | Current |