fexofenadine hcl
- Product NDC
- 50228-201
- 11-digit product format
- 502280201
- Labeler code
- 50228
- Product ID
- 50228-201_2a0b48b8-5955-9ab7-e063-6394a90a6b24
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hcl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2014-12-26
- 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 hcl
- 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 | 997420, 997501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-201-01 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 50228-201-02 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 50228-201-03 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 50228-201-04 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-201 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241226_b7e9477d-33d9-4463-b8a6-69af5f71ce35.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 |
|---|
| 50228-201-01 | 50228020101 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01) | 2014-12-26 | 0000-00-00 | No | No | Current |
| 50228-201-02 | 50228020102 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02) | 2014-12-26 | 0000-00-00 | No | No | Current |
| 50228-201-03 | 50228020103 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03) | 2014-12-26 | 0000-00-00 | No | No | Current |
| 50228-201-04 | 50228020104 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04) | 2014-12-26 | 0000-00-00 | No | No | Current |