fexofenadine hcl
- Product NDC
- 71335-2165
- 11-digit product format
- 713352165
- Labeler code
- 71335
- Product ID
- 71335-2165_04a27808-de0a-4100-9aff-3168e4fd231e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hcl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2021-08-26
- 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 | 997501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2165-1 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 104 |
| 71335-2165-2 | fexofenadine hcl | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 104 |
| 71335-2165-3 | fexofenadine hcl | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 104 |
| 71335-2165-4 | fexofenadine hcl | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 104 |
| 71335-2165-5 | fexofenadine hcl | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 104 |
| 71335-2165-6 | fexofenadine hcl | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 104 |
| 71335-2165-7 | fexofenadine hcl | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2165 | FEXOFENADINE HCL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 7 package rows | 20240925_c23ad304-a5de-454e-a135-4eb143af2381.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 |
|---|
| 71335-2165-1 | 71335216501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1) | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-2165-2 | 71335216502 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2) | 2022-08-25 | 0000-00-00 | No | No | Current |
| 71335-2165-3 | 71335216503 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3) | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-2165-4 | 71335216504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4) | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-2165-5 | 71335216505 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5) | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-2165-6 | 71335216506 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6) | 2024-09-06 | 0000-00-00 | No | No | Current |
| 71335-2165-7 | 71335216507 | 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7) | 2022-11-08 | | No | No | Historical |