FEXOFENADINE HCl
- Product NDC
- 70677-1239
- 11-digit product format
- 706771239
- Labeler code
- 70677
- Product ID
- 70677-1239_498a79fc-c2a8-c5ea-e063-6294a90ab355
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services, LLC
- Application
- ANDA210137
- Marketing category
- ANDA
- Marketing start
- 2024-02-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | | | 2018-08-13 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FEXOFENADINE HCl
- Listing expiration
- 2027-12-31
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 |
|---|
| 70677-1239-1 | FEXOFENADINE HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70677-1239 | FEXOFENADINE HCL TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC] | 3 | Current NDC, 1 package rows | 20250101_7a49f700-5892-404b-b81a-4a92c1928806.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70677-1239-1 | 70677123901 | 100 TABLET, FILM COATED in 1 BOTTLE (70677-1239-1) | 2024-02-22 | No | No | Current |