FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 62756-545
- 11-digit product format
- 627560545
- Labeler code
- 62756
- Product ID
- 62756-545_ba7aefbb-bb1a-44fd-b62e-53aeb9cbbaab
- 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
- 2022-06-30
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-545-15 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 10 | |
| 62756-545-17 | FEXOFENADINE HYDROCHLORIDE | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | 10 | |
| 62756-545-18 | FEXOFENADINE HYDROCHLORIDE | 70 in 1 BOTTLE | TABLET, FILM COATED | 70 | 10 | |
| 62756-545-19 | FEXOFENADINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 10 | |
| 62756-545-20 | FEXOFENADINE HYDROCHLORIDE | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | 10 | |
| 62756-545-21 | FEXOFENADINE HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | 10 | |
| 62756-545-22 | FEXOFENADINE HYDROCHLORIDE | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 10 | |
| 62756-545-25 | FEXOFENADINE HYDROCHLORIDE | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 10 | |
| 62756-545-27 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 10 | |
| 62756-545-31 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 10 | |
| 62756-545-94 | FEXOFENADINE HYDROCHLORIDE | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 10 | |
| 62756-545-64 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 CARTON | TABLET, FILM COATED | 5 | 6 | |
| 62756-545-64 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | 6 | |
| 62756-545-66 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 6 | |
| 62756-545-66 | FEXOFENADINE HYDROCHLORIDE | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 6 | |
| 62756-545-74 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 62756-545-74 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 6 | |
| 62756-545-76 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | 6 | |
| 62756-545-76 | FEXOFENADINE HYDROCHLORIDE | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 6 | |
| 62756-545-77 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 6 | |
| 62756-545-77 | FEXOFENADINE HYDROCHLORIDE | 9 in 1 CARTON | TABLET, FILM COATED | 9 | 6 | |
| 62756-545-78 | FEXOFENADINE HYDROCHLORIDE | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | 6 | |
| 62756-545-78 | FEXOFENADINE HYDROCHLORIDE | 15 in 1 CARTON | TABLET, FILM COATED | 15 | 6 | |
| 62756-545-83 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 6 | |
| 62756-545-88 | FEXOFENADINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62756-545 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Legacy NDC, 11 package rows | 20220701_47826458-4f7f-486b-aec4-ae48c3f94f5e.zip |
| 62756-545 | 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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 47826458-4f7f-486b-aec4-ae48c3f94f5e | 10 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 47826458-4f7f-486b-aec4-ae48c3f94f5e | 10 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 47826458-4f7f-486b-aec4-ae48c3f94f5e | 10 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997488 | fexofenadine HCl 30 MG Oral Tablet | PSN | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997488 | fexofenadine hydrochloride 30 MG Oral Tablet | SCD | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 04923af6-97fc-4e32-834d-1df643832d7f | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-545-15 | 62756054515 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-545-15) | 2012-02-06 | 0000-00-00 | No | No | Current | |
| 62756-545-16 | 62756054516 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-545-16) | 2012-02-06 | 0000-00-00 | No | No | Current | |
| 62756-545-17 | 62756054517 | 45 TABLET, FILM COATED in 1 BOTTLE (62756-545-17) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-18 | 62756054518 | 70 TABLET, FILM COATED in 1 BOTTLE (62756-545-18) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-19 | 62756054519 | 90 TABLET, FILM COATED in 1 BOTTLE (62756-545-19) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-20 | 62756054520 | 150 TABLET, FILM COATED in 1 BOTTLE (62756-545-20) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-21 | 62756054521 | 180 TABLET, FILM COATED in 1 BOTTLE (62756-545-21) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-22 | 62756054522 | 300 TABLET, FILM COATED in 1 BOTTLE (62756-545-22) | 2022-06-30 | 0000-00-00 | No | No | Current | |
| 62756-545-25 | 62756054525 | 3 BLISTER PACK in 1 CARTON (62756-545-25) > 5 TABLET, FILM COATED in 1 BLISTER PACK (62756-545-31) | 3 blister pack | 2022-06-30 | 0000-00-00 | No | No | Current |
| 62756-545-27 | 62756054527 | 1 BLISTER PACK in 1 CARTON (62756-545-27) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-28 | 62756054528 | 9 BLISTER PACK in 1 CARTON (62756-545-28) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-29 | 62756054529 | 10 BLISTER PACK in 1 CARTON (62756-545-29) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-30 | 62756054530 | 15 BLISTER PACK in 1 CARTON (62756-545-30) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-31 | 62756054531 | 5 in 1 BLISTER PACK | Historical | |||||
| 62756-545-64 | 62756054564 | 5 BLISTER PACK in 1 CARTON (62756-545-64) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-66 | 62756054566 | 2 BLISTER PACK in 1 CARTON (62756-545-66) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-74 | 62756054574 | 1 BLISTER PACK in 1 CARTON (62756-545-74) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-76 | 62756054576 | 10 BLISTER PACK in 1 CARTON (62756-545-76) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-77 | 62756054577 | 9 BLISTER PACK in 1 CARTON (62756-545-77) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-78 | 62756054578 | 15 BLISTER PACK in 1 CARTON (62756-545-78) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |
| 62756-545-83 | 62756054583 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-545-83) | 2012-02-06 | 0000-00-00 | No | No | Current | |
| 62756-545-88 | 62756054588 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-545-88) | 2012-02-06 | 0000-00-00 | No | No | Current | |
| 62756-545-94 | 62756054594 | 2 BLISTER PACK in 1 CARTON (62756-545-94) > 5 TABLET, FILM COATED in 1 BLISTER PACK (62756-545-31) | 2 blister pack | 2022-06-30 | 0000-00-00 | No | No | Current |
| 62756-545-95 | 62756054595 | 5 BLISTER PACK in 1 CARTON (62756-545-95) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2012-02-06 | 0000-00-00 | No | No | Current |