Fexofenadine hydrochloride
- Product NDC
- 55111-784
- 11-digit product format
- 551110784
- Labeler code
- 55111
- Product ID
- 55111-784_9c0b82c6-7eff-3eec-40e2-db72a8625eff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2011-01-03
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 55111-784 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 | ||
| unfinished package | package | 55111-784 | 55111-784-89 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 55111-784-89 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 55111-784-89 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 55111-784-89 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 55111-784-89 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 55111-784-89 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 55111-784-89 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 55111-784-89 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 55111-784-89 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 55111-784-89 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 55111-784-89 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 55111-784-89 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 55111-784-89 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 55111-784-89 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 55111-784-89 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 55111-784-89 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 55111-784-89 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 55111-784-89 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 55111-784-89 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 55111-784-89 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 55111-784-89 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 55111-784-89 | 5b2001dcd8f5… | 54b53d4dc9e4… |
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 | 180 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 864e3052-5787-bf11-9d17-11274ca2304f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-784-01 | EA - Each | 55111-784 | fcfbe779-dfaf-4c1a-b197-12b0a5ca5247 | 1 | 2018-12-13 |
| 55111-784-30 | EA - Each | 55111-784 | 9ca6ce31-a274-408f-b03e-0b74b74bc4fd | 1 | 2015-09-10 |
DailyMed Socrata Ingredients#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997488 | fexofenadine HCl 30 MG Oral Tablet | PSN | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997488 | fexofenadine hydrochloride 30 MG Oral Tablet | SCD | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 864e3052-5787-bf11-9d17-11274ca2304f | 19 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 204506d7-7688-fd7e-0aae-142b698848ef | 9 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 204506d7-7688-fd7e-0aae-142b698848ef | 9 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 204506d7-7688-fd7e-0aae-142b698848ef | 9 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 1b2a14a1-a5cc-4f5e-8127-57e9d913f50a | 7 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 1b2a14a1-a5cc-4f5e-8127-57e9d913f50a | 7 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 1b2a14a1-a5cc-4f5e-8127-57e9d913f50a | 7 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 8917abc8-d391-89d1-ef3b-19e1702bc83d | 6 |
| 1116528 | Wal-Fex Allergy 180 MG 24HR Oral Tablet | PSN | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 1116528 | fexofenadine hydrochloride 180 MG Oral Tablet [Wal-Fex] | SBD | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 8917abc8-d391-89d1-ef3b-19e1702bc83d | 6 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 8917abc8-d391-89d1-ef3b-19e1702bc83d | 6 |
| 1116528 | Wal-Fex 24 HR 180 MG Oral Tablet | SY | 95d420ea-6337-304f-54c3-0c75be1608e2 | 6 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 7b146260-c925-3238-d092-24b7101ceb50 | 5 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 0a6da401-a8a3-5d0b-f37e-c220838f7e49 | 5 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 7b146260-c925-3238-d092-24b7101ceb50 | 5 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 0a6da401-a8a3-5d0b-f37e-c220838f7e49 | 5 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 0a6da401-a8a3-5d0b-f37e-c220838f7e49 | 5 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 7b146260-c925-3238-d092-24b7101ceb50 | 5 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | f532e9d5-6457-8bef-e83e-16050f20b03c | 4 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce | 4 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | f532e9d5-6457-8bef-e83e-16050f20b03c | 4 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce | 4 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | f532e9d5-6457-8bef-e83e-16050f20b03c | 4 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce | 4 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 624b3a91-af4f-8848-6fc3-392e0df34cc8 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | d1d8d0ec-2bdd-fb07-a051-d6353e3c240c | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 3c30a1dc-a13d-2522-d4d0-00c1e9dbab07 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 8a1de8a1-808a-bc08-6c74-957d6f388eab | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 624b3a91-af4f-8848-6fc3-392e0df34cc8 | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 3c30a1dc-a13d-2522-d4d0-00c1e9dbab07 | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | d1d8d0ec-2bdd-fb07-a051-d6353e3c240c | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 8a1de8a1-808a-bc08-6c74-957d6f388eab | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | d1d8d0ec-2bdd-fb07-a051-d6353e3c240c | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 624b3a91-af4f-8848-6fc3-392e0df34cc8 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 8a1de8a1-808a-bc08-6c74-957d6f388eab | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 3c30a1dc-a13d-2522-d4d0-00c1e9dbab07 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 3cf4b7fe-b1f7-b767-430a-655408f91753 | 2 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 1c1f43c4-7128-37c4-83fe-7eefac3fd477 | 2 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 3cf4b7fe-b1f7-b767-430a-655408f91753 | 2 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 1c1f43c4-7128-37c4-83fe-7eefac3fd477 | 2 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 1c1f43c4-7128-37c4-83fe-7eefac3fd477 | 2 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 3cf4b7fe-b1f7-b767-430a-655408f91753 | 2 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | dda452db-25a0-4409-96dd-a13ee73eba0b | 1 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | de438313-9790-b4ea-2d28-7a19836cf5e2 | 1 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | dda452db-25a0-4409-96dd-a13ee73eba0b | 1 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | de438313-9790-b4ea-2d28-7a19836cf5e2 | 1 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | dda452db-25a0-4409-96dd-a13ee73eba0b | 1 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | de438313-9790-b4ea-2d28-7a19836cf5e2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-784-01 | 55111078401 | 1 BOTTLE in 1 CARTON (55111-784-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-05 | 55111078405 | 1 BOTTLE in 1 CARTON (55111-784-05) / 500 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-07 | 55111078407 | 1 BLISTER PACK in 1 CARTON (55111-784-07) / 5 TABLET in 1 BLISTER PACK | 1 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-15 | 55111078415 | 1 BOTTLE in 1 CARTON (55111-784-15) / 150 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-18 | 55111078418 | 1 BOTTLE in 1 CARTON (55111-784-18) / 180 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-23 | 55111078423 | 1 BLISTER PACK in 1 CARTON (55111-784-23) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-28 | 55111078428 | 3 BLISTER PACK in 1 CARTON (55111-784-28) / 15 TABLET in 1 BLISTER PACK | 3 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-29 | 55111078429 | 3 BLISTER PACK in 1 CARTON (55111-784-29) / 5 TABLET in 1 BLISTER PACK | 3 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-30 | 55111078430 | 1 BOTTLE in 1 CARTON (55111-784-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-35 | 55111078435 | 2 BLISTER PACK in 1 CARTON (55111-784-35) / 5 TABLET in 1 BLISTER PACK | 2 blister pack | 2021-12-01 | 0000-00-00 | No | No | Current |
| 55111-784-40 | 55111078440 | 1 BOTTLE in 1 CARTON (55111-784-40) / 40 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-43 | 55111078443 | 2 BOTTLE in 1 CARTON (55111-784-43) / 30 TABLET in 1 BOTTLE | 2 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-45 | 55111078445 | 1 BOTTLE in 1 CARTON (55111-784-45) / 45 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-59 | 55111078459 | 2 BOTTLE in 1 CARTON (55111-784-59) / 60 TABLET in 1 BOTTLE | 2 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-75 | 55111078475 | 1 BOTTLE in 1 CARTON (55111-784-75) / 70 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-78 | 55111078478 | 10 BLISTER PACK in 1 CARTON (55111-784-78) / 10 TABLET in 1 BLISTER PACK (55111-784-79) | 10 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-784-89 | 55111078489 | 1500 TABLET in 1 POUCH (55111-784-89) | 1500 tablet | 17-FEB-16 | Current | |||
| 55111-784-90 | 55111078490 | 1 BOTTLE in 1 CARTON (55111-784-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2011-01-03 | 0000-00-00 | No | No | Current |