FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 62756-542
- 11-digit product format
- 627560542
- Labeler code
- 62756
- Product ID
- 62756-542_754f554d-91c6-4314-870c-b87e9a386153
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091567
- Marketing category
- ANDA
- Marketing start
- 2012-02-06
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 30 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 62756-542-64 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-66 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-74 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-76 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-77 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-78 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-83 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
| 62756-542-88 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d6d-0266-e053-dadaa90a7c1a | Fexofenadine Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-542-64 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 6 |
| 62756-542-64 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 6 |
| 62756-542-66 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 6 |
| 62756-542-66 | FEXOFENADINE HYDROCHLORIDE | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 6 |
| 62756-542-74 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 6 |
| 62756-542-74 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 62756-542-76 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 6 |
| 62756-542-76 | FEXOFENADINE HYDROCHLORIDE | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 62756-542-77 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 6 |
| 62756-542-77 | FEXOFENADINE HYDROCHLORIDE | 9 in 1 CARTON | TABLET, FILM COATED | 9 | | 6 |
| 62756-542-78 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 6 |
| 62756-542-78 | FEXOFENADINE HYDROCHLORIDE | 15 in 1 CARTON | TABLET, FILM COATED | 15 | | 6 |
| 62756-542-83 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 62756-542-88 | FEXOFENADINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
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 [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-542 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Legacy NDC, 14 package rows | 20181026_04923af6-97fc-4e32-834d-1df643832d7f.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 |
|---|
| 62756-542-15 | 62756054215 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-542-15) | | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-16 | 62756054216 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-542-16) | | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-27 | 62756054227 | 1 BLISTER PACK in 1 CARTON (62756-542-27) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-28 | 62756054228 | 9 BLISTER PACK in 1 CARTON (62756-542-28) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-29 | 62756054229 | 10 BLISTER PACK in 1 CARTON (62756-542-29) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-30 | 62756054230 | 15 BLISTER PACK in 1 CARTON (62756-542-30) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-64 | 62756054264 | 5 BLISTER PACK in 1 CARTON (62756-542-64) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-66 | 62756054266 | 2 BLISTER PACK in 1 CARTON (62756-542-66) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-74 | 62756054274 | 1 BLISTER PACK in 1 CARTON (62756-542-74) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-76 | 62756054276 | 10 BLISTER PACK in 1 CARTON (62756-542-76) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-77 | 62756054277 | 9 BLISTER PACK in 1 CARTON (62756-542-77) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-78 | 62756054278 | 15 BLISTER PACK in 1 CARTON (62756-542-78) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-83 | 62756054283 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-542-83) | | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-88 | 62756054288 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-542-88) | | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-94 | 62756054294 | 2 BLISTER PACK in 1 CARTON (62756-542-94) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-542-95 | 62756054295 | 5 BLISTER PACK in 1 CARTON (62756-542-95) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |