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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S068B75ZU | FEXOFENADINE HYDROCHLORIDE | 153439-40-8 | FEXOFENADINE HYDROCHLORIDE |
Packages
| 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 | Historical |
| 71610-905-53 | 71610090553 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) | 2025-05-07 | No | No | Historical |
| 71610-905-60 | 71610090560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) | 2025-05-07 | No | No | Historical |
| 71610-905-80 | 71610090580 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80) | 2025-05-07 | No | No | Historical |