fexofenadine hcl
- Product NDC
- 71610-905
- 11-digit product format
- 716100905
- Labeler code
- 71610
- Product ID
- 71610-905_34917b34-89a7-2a13-e063-6394a90a9038
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hcl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2025-03-10
- 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
- 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 | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997420 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-905-30 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71610-905-53 | fexofenadine hcl | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 71610-905-60 | fexofenadine hcl | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 71610-905-80 | fexofenadine hcl | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-905 | FEXOFENADINE HCL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] | 1 | Current NDC, 4 package rows | 20250515_34918a5a-c4c9-bc79-e063-6294a90acb85.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-905-30 | 71610090530 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30) | 2025-05-07 | No | No | Current |
| 71610-905-53 | 71610090553 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) | 2025-05-07 | No | No | Current |
| 71610-905-60 | 71610090560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) | 2025-05-07 | No | No | Current |
| 71610-905-80 | 71610090580 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80) | 2025-05-07 | No | No | Current |