FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 0615-8648
- 11-digit product format
- 006158648
- Labeler code
- 0615
- Product ID
- 0615-8648_91c36b66-1f6a-4ff2-8a68-f87b323c70da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA091567
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 |
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 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… |
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 | 180 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 997420 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 58193632-2468-4159-b1a9-c24a489f199f | 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 58193632-2468-4159-b1a9-c24a489f199f | 2026-06-24 | Warnings | 091567 ANDA091567 0615-8648 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | OHM LABORATORIES INC. | 1a1afa95-570d-456e-b436-a0fcfaf68517 | 2026-05-05 | Warnings | 091567 ANDA091567 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | CVS PHARMACY, INC | 7bc13851-291a-4582-8261-13c5022fbdd1 | 2024-05-24 | Warnings | 091567 ANDA091567 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | AMERISOURCE BERGEN | 2a578643-adc1-44ca-83f2-9d48527bd3a4 | 2024-05-14 | Warnings | 091567 ANDA091567 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0615-8648-39 | 00615864839 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8648-39) | 2026-06-23 | No | No | Current |