Fexofenadine HCL
- Product NDC
- 21130-769
- 11-digit product format
- 211300769
- Labeler code
- 21130
- Product ID
- 21130-769_46510eff-7092-0dba-e063-6394a90a9881
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safeway, Inc
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2023-11-06
- 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 |
|---|
| 21130-769-03 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 21130-769-07 | Fexofenadine HCL | 15 in 1 BLISTER PACK | TABLET | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-769 | FEXOFENADINE HCL TABLET [SAFEWAY, INC] | 4 | Current NDC, 2 package rows | 20241212_f32e9cb6-af93-e60a-e053-2995a90a42f5.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 |
|---|
| 21130-769-03 | 21130076903 | 30 TABLET in 1 BOTTLE (21130-769-03) | 30 tablet | 2023-11-06 | No | No | Current |
| 21130-769-07 | 21130076907 | 15 TABLET in 1 BLISTER PACK (21130-769-07) | 15 tablet | 2023-11-06 | No | No | Current |