FENOFIBRATE
- Product NDC
- 72603-841
- 11-digit product format
- 726030841
- Labeler code
- 72603
- Product ID
- 72603-841_14f18477-a8d7-4aea-82cb-f0100e6c24a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA213864
- Marketing category
- ANDA
- Marketing start
- 2025-09-29
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FENOFIBRATE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FENOFIBRATE | 160 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72603-841-01 | FENOFIBRATE | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 72603-841-02 | FENOFIBRATE | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72603-841-01 | EA - Each | 72603-841 | 2b7df630-30ed-4514-8f51-34792c350472 | 1 | 2025-11-13 |
| 72603-841-02 | EA - Each | 72603-841 | 810b4860-0fad-4271-a6f7-ed00c1cfa4d4 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349287 | fenofibrate 160 MG Oral Tablet | PSN | df9f67d6-3cd9-4f44-8020-2d6ef53c30b5 | 3 |
| 349287 | fenofibrate 160 MG Oral Tablet | SCD | df9f67d6-3cd9-4f44-8020-2d6ef53c30b5 | 3 |
| 349287 | fenofibrate 160 MG Oral Tablet | PSN | 3b448774-aebf-45fe-92f1-b8eca53cf09b | 1 |
| 349287 | fenofibrate 160 MG Oral Tablet | PSN | f443dd79-46da-4b02-8188-7417d39cf975 | 1 |
| 351133 | fenofibrate 54 MG Oral Tablet | PSN | 3b448774-aebf-45fe-92f1-b8eca53cf09b | 1 |
| 349287 | fenofibrate 160 MG Oral Tablet | SCD | 3b448774-aebf-45fe-92f1-b8eca53cf09b | 1 |
| 349287 | fenofibrate 160 MG Oral Tablet | SCD | f443dd79-46da-4b02-8188-7417d39cf975 | 1 |
| 351133 | fenofibrate 54 MG Oral Tablet | SCD | 3b448774-aebf-45fe-92f1-b8eca53cf09b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72603-841-01 | 72603084101 | 90 TABLET in 1 BOTTLE (72603-841-01) | 90 tablet | 2025-09-29 | No | No | Current |
| 72603-841-02 | 72603084102 | 500 TABLET in 1 BOTTLE (72603-841-02) | 500 tablet | 2025-09-29 | No | No | Current |