FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 58602-427
- 11-digit product format
- 586020427
- Labeler code
- 58602
- Product ID
- 58602-427_fe864426-c0d6-492a-96be-cd44fd9ca054
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE ORAL
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213466
- Marketing category
- ANDA
- Marketing start
- 2026-08-31
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 30 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213466-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | 3f0d92c62455… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213466-001 | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | 2023-05-23 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FEXOFENADINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 997491 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fe864426-c0d6-492a-96be-cd44fd9ca054 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE ORAL | Aurohealth LLC | fe864426-c0d6-492a-96be-cd44fd9ca054 | 2026-09-01 | Warnings | 213466 ANDA213466 58602-427 |
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE ORAL | Aurohealth LLC | e8e35d7a-a86b-4d37-979b-f454978f070b | 2023-06-06 | Warnings | 213466 ANDA213466 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58602-427-20 | 58602042720 | 1 BOTTLE in 1 CARTON (58602-427-20) / 240 mL in 1 BOTTLE | 1 bottle | 2026-08-31 | No | No | Current |
| 58602-427-24 | 58602042724 | 1 BOTTLE in 1 CARTON (58602-427-24) / 120 mL in 1 BOTTLE | 1 bottle | 2026-08-31 | No | No | Current |