Fenofibric Acid
- Product NDC
- 53489-677
- 11-digit product format
- 534890677
- Labeler code
- 53489
- Product ID
- 53489-677_65f745e9-1116-4c2a-9de8-f64fbf92f641
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mutual Pharmaceutical Company, Inc.
- Application
- NDA022418
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-08-31
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRIC ACID
- Active strength
- 35 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53489-677 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 53489-677 | 53489-677-07 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022418-001 | FIBRICOR | FENOFIBRIC ACID | 35MG | TABLET / ORAL | RLD | 2009-08-14 | |
| N022418-002 | FIBRICOR | FENOFIBRIC ACID | 105MG | TABLET / ORAL | RLD | 2009-08-14 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022418-001 | 7569612 | 2027-08-20 | U-1000 | ||
| N022418-001 | 7741373 | 2027-08-20 | U-1059 | ||
| N022418-001 | 7741374 | 2027-08-20 | U-1061 | ||
| N022418-001 | 7741374 | 2027-08-20 | U-1060 | ||
| N022418-001 | 7915247 | 2027-08-20 | U-1061 | 2011-03-30 | |
| N022418-001 | 7915247 | 2027-08-20 | U-1059 | 2011-03-30 | |
| N022418-001 | 7915247 | 2027-08-20 | U-1000 | 2011-03-30 | |
| N022418-002 | 7569612 | 2027-08-20 | U-1000 | ||
| N022418-002 | 7741373 | 2027-08-20 | U-1059 | ||
| N022418-002 | 7741374 | 2027-08-20 | U-1061 | ||
| N022418-002 | 7741374 | 2027-08-20 | U-1060 | ||
| N022418-002 | 7915247 | 2027-08-20 | U-1000 | ||
| N022418-002 | 7915247 | 2027-08-20 | U-1059 | ||
| N022418-002 | 7915247 | 2027-08-20 | U-1061 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53489-677-07 | EA - Each | 53489-677 | accd2654-5d7e-4073-b5db-81248203cdb7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fenofibric Acid | ACTIVE INGREDIENT | BGF9MN2HU1 | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Fenofibric Acid | ACTIVE MOIETY | BGF9MN2HU1 | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Copovidone K25-31 | INACTIVE INGREDIENT | D9C330MD8B | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRIC ACID TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 |