Fexofenadine hydrochloride
- Product NDC
- 0363-0783
- 11-digit product format
- 003630783
- Labeler code
- 0363
- Product ID
- 0363-0783_99bc952b-03e9-cb28-9669-ce7dfef79b0d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Walgreens Company
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2020-12-14
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076502-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076502-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076502-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b961985e-0c18-b36f-d82e-32ff2d46fada | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0783-24 | 2024-01-30 | C162847 | 48780-1 | 1030e365-082d-111a-e063-dadaa90a10e2 | Fexofenadine HCl Tablets USP |
| 0363-0783-24 | 2024-01-30 | C162847 | 48780-1 | 1030e365-082d-111a-e063-dadaa90a10e2 | Fexofenadine HCl Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0783-24 | Fexofenadine hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | 4 | |
| 0363-0783-24 | Fexofenadine hydrochloride | 4 in 1 CARTON | TABLET | 4 | 4 |
DailyMed Dashboard NDC Coverage#
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0783-24 | 00363078324 | 4 BLISTER PACK in 1 CARTON (0363-0783-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2020-12-14 | 0000-00-00 | No | No | Current |