Fexofenadine hydrochloride
- Product NDC
- 53943-021
- 11-digit product format
- 539430021
- Labeler code
- 53943
- Product ID
- 53943-021_1d982c6e-4506-410b-82d8-602993fd5805
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- ANDA202039
- Marketing category
- ANDA
- Marketing start
- 2015-05-06
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 53943-021-09 | Fexofenadine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 53943-021-09 | Fexofenadine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 53943-021-17 | Fexofenadine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 53943-021-17 | Fexofenadine hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 2 |
| 53943-021-60 | Fexofenadine hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 2 |
| 53943-021-85 | Fexofenadine hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-021 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART] | 2 | Legacy NDC, 6 package rows | 20190911_ab09fd7c-b1a7-4bf9-9f86-801331a6588e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53943-021-09 | 53943002109 | 1 BOTTLE in 1 CARTON (53943-021-09) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-05-06 | 0000-00-00 | No | No | Current |
| 53943-021-17 | 53943002117 | 1 BOTTLE in 1 CARTON (53943-021-17) > 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-05-06 | 0000-00-00 | No | No | Current |
| 53943-021-60 | 53943002160 | 5 in 1 BLISTER PACK | | | | | | Historical |
| 53943-021-85 | 53943002185 | 3 BLISTER PACK in 1 CARTON (53943-021-85) > 5 TABLET, FILM COATED in 1 BLISTER PACK (53943-021-60) | 3 blister pack | 2015-05-06 | 0000-00-00 | No | No | Current |