FENOFIBRATE
- Product NDC
- 68071-2540
- 11-digit product format
- 680712540
- Labeler code
- 68071
- Product ID
- 68071-2540_e674720f-dc2a-0824-e053-2995a90a4cd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA213864
- Marketing category
- ANDA
- Marketing start
- 2020-09-10
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 68071-2540 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 68071-2540 | 68071-2540-9 | I | Inactivated by FDA | 2026-08-17 |
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 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2540-9 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2540-9 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2540-9 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2540-9 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213864-001 | FENOFIBRATE | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | |
| A213864-002 | FENOFIBRATE | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213864-001 | AB |
| A213864-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213864-001 | FENOFIBRATE | 54MG | TABLET / ORAL | AB | 2020-06-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213864-002 | FENOFIBRATE | 160MG | TABLET / ORAL | AB | 2020-06-12 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213864-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213864-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213864-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213864-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213864-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213864-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213864-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213864-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213864-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213864-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213864-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213864-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213864-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213864-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213864-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213864-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213864-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213864-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213864-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213864-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213864-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213864-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213864-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213864-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213864-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213864-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213864-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213864-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213864-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213864-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213864-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213864-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213864-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213864-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213864-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213864-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213864-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213864-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213864-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213864-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 193bb7da-5c03-8f95-9048-23ef403846b0 | Product name | 3 | 20250616 |
| fa35fb9a-7146-716b-13c8-bc1f60030232 | Product name | 9 | 20250114 |
| cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07 | Product name | 8 | 20231212 |
| 53d5b6b7-785a-4500-9460-263c7f8424b8 | Product name | 5 | 20210105 |
| ed9d55d4-85bd-0ee7-5b4a-b705646a3a66 | Product name | 9 | 20200708 |
| 36a239c8-03fb-0083-81af-6c1afb195671 | Product name | 1 | 20140508 |
| a0296d70-ca85-018c-84e8-cf3f630976b7 | Product name | 1 | 20140508 |
| f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2540-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-93af-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2540-9 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2540 | FENOFIBRATE TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Legacy NDC, 1 package rows | 20230715_cc85c6cc-7fd4-4013-e053-2a95a90aa5d1.zip |
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 |
|---|---|---|---|---|---|---|
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | 3b6c5ebd-a8bc-4502-8b66-f4e58914815b | 2026-07-30 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | St. Mary's Medical Park Pharmacy | b92fb19a-d0df-426e-e053-2995a90ab379 | 2026-06-02 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | df9f67d6-3cd9-4f44-8020-2d6ef53c30b5 | 2026-05-08 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Preferred Pharmaceuticals Inc. | e573b3f1-5a4c-4a19-9f0f-ee797b379a08 | 2026-04-15 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | f443dd79-46da-4b02-8188-7417d39cf975 | 2026-03-10 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | b79efcf4-6016-4a1f-b83f-be00baa25c21 | 2026-02-13 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Northwind Health Company, LLC | f7590970-c54d-24e9-e053-6294a90ac400 | 2026-01-01 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | NorthStar RxLLC | 3b448774-aebf-45fe-92f1-b8eca53cf09b | 2025-09-13 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Major Pharmaceuticals | 3f4e5db8-5bfb-4b24-8465-9757cbaad2be | 2025-06-02 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Lifestar Pharma LLC | 1da57e8c-3977-43e1-aa7e-229760203f7d | 2025-05-28 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Bryant Ranch Prepack | d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5 | 2023-03-31 | Warnings, Adverse reactions | 213864 ANDA213864 |
| FENOFIBRATE | FENOFIBRATE | Proficient Rx LP | 26f8f793-fb7a-4327-9441-d8737fe1ff11 | 2022-06-01 | Warnings, Adverse reactions | 213864 ANDA213864 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349287 | fenofibrate 160 MG Oral Tablet | PSN | cc85c6cc-7fd4-4013-e053-2a95a90aa5d1 | 3 |
| 349287 | fenofibrate 160 MG Oral Tablet | SCD | cc85c6cc-7fd4-4013-e053-2a95a90aa5d1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2540-9 | 68071254009 | 90 TABLET in 1 BOTTLE (68071-2540-9) | 90 tablet | 2021-09-21 | 0000-00-00 | No | No | Current |