Fexofenadine HCl
- Product NDC
- 63187-921
- 11-digit product format
- 631870921
- Labeler code
- 63187
- Product ID
- 63187-921_9d96cb6a-14e9-4dcb-84e4-63d98a716070
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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 |
|---|
| 63187-921-20 | Fexofenadine HCl | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 63187-921-30 | Fexofenadine HCl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 63187-921-60 | Fexofenadine HCl | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 63187-921-90 | Fexofenadine HCl | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-921 | FEXOFENADINE HCL TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20191108_3b147968-c6a8-4725-89b6-2eb443900e8f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-921-20 | 63187092120 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20) | 2017-10-02 | 0000-00-00 | No | No | Current |
| 63187-921-30 | 63187092130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30) | 2017-10-02 | 0000-00-00 | No | No | Current |
| 63187-921-60 | 63187092160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60) | 2017-10-02 | 0000-00-00 | No | No | Current |
| 63187-921-90 | 63187092190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90) | 2017-10-02 | 0000-00-00 | No | No | Current |