Fexofenadine Hydrochloride
- Product NDC
- 68071-3228
- Requested package NDC
- 68071-3228-3
- 11-digit product format
- 680713228
- Labeler code
- 68071
- Product ID
- 68071-3228_bbf19d03-48e7-aab7-e053-2a95a90a9cae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA076447
- Marketing category
- ANDA
- Marketing start
- 2011-08-08
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 68071-3228 | 68071-3228-3 | D | Discontinued by firm | 2026-10-05 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076447-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-13 |
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 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076447-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076447-001 | AB | 1 | 8072bd15b7f6… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
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 |
|---|---|---|---|---|---|---|
| CareOne Allergy Relief | FEXOFENADINE HCL | American Sales Company | 65720e72-c20d-4363-92ab-76596e043bc0 | 2021-07-12 | Warnings | 076447 ANDA076447 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3228-3 | 68071322803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3228-3) | 2017-05-05 | 0000-00-00 | No | No | Current |