Fexofenadine Hydrochloride
- Product NDC
- 10544-231
- 11-digit product format
- 105440231
- Labeler code
- 10544
- Product ID
- 10544-231_11926194-a657-2bfb-e054-00144ff88e88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA076447
- Marketing category
- ANDA
- Marketing start
- 2013-11-13
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-231-30 | Fexofenadine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-231 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150318_11926194-a656-2bfb-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-231-30 | 10544023130 | 30 in 1 BOTTLE | Historical |