Fexofenadine Hydrochloride
- Product NDC
- 0615-5620
- 11-digit product format
- 006155620
- Labeler code
- 0615
- Product ID
- 0615-5620_f671bdae-9654-4623-9ef2-b934fc5c1bfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- NDA020872
- Marketing category
- NDA
- Marketing start
- 2000-02-25
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0615-5620 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0615-5620 | 0615-5620-39 | D | Discontinued by firm | 2026-08-11 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0615-5620-39 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0615-5620-39 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020872-005 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-006 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-007 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-008 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-009 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | |
| N020872-010 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 |
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 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0615-5620-39 | 2022-11-22 | C162847 | 48780-1 | 9d75b9d0-994f-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets |
| 0615-5620-39 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-994f-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Allegra Allergy, Travel BASIX | FEXOFENADINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | b82d993a-16ff-4037-a182-7010de8e1cdd | 2026-04-27 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | e8a00fa1-79af-4ce6-885f-0ce12c5da836 | 2026-04-22 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 2026-04-14 | Warnings | 020872 NDA020872 |
| Allegra Hives 24hr | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | 490b4c5f-448b-4563-928b-837117b59b9f | 2026-01-12 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | f061d6b1-89f7-4d5f-ac59-9c73408517c1 | 2025-02-19 | Warnings | 020872 NDA020872 |
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | A-S Medication Solutions | b5ce28f8-f6c3-4113-9317-e1c98e5030ef | 2024-07-30 | Warnings | 020872 NDA020872 |