FIBRICOR
- Product NDC
- 71511-502
- 11-digit product format
- 715110502
- Labeler code
- 71511
- Product ID
- 71511-502_f1aa0095-4a2d-42cf-b4f5-b88e0f55a4e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Athena Bioscience, LLC
- Application
- NDA022418
- Marketing category
- NDA
- Marketing start
- 2017-08-05
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRIC ACID
- Active strength
- 105 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 71511-502 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 71511-502 | 71511-502-30 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| 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 |
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71511-502-30 | 71511050230 | 30 TABLET in 1 BOTTLE, PLASTIC (71511-502-30) | 30 tablet | 2019-03-15 | 0000-00-00 | No | No | Current |