FIBRICOR
- Product NDC
- 69916-035
- 11-digit product format
- 699160035
- Labeler code
- 69916
- Product ID
- 69916-035_31112335-e6c0-4c10-b5db-8cf4c4c74d65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Tribute Pharmaceuticals US, Inc.
- Application
- NDA022418
- Marketing category
- NDA
- Marketing start
- 2015-07-30
- 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
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69916-035-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcc8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69916-035-30 | FIBRICOR | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69916-035-30 | EA - Each | 69916-035 | 4b53bf65-ebe8-4009-b3ad-d716423db874 | 1 | 2016-04-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fenofibric Acid | ACTIVE INGREDIENT | BGF9MN2HU1 | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 | |
| Fenofibric Acid | ACTIVE MOIETY | BGF9MN2HU1 | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 | |
| Copovidone K25-31 | INACTIVE INGREDIENT | D9C330MD8B | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860880 | fenofibric acid 105 MG Oral Tablet | PSN | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860886 | fenofibric acid 35 MG Oral Tablet | PSN | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860884 | FIBRICOR 105 MG Oral Tablet | PSN | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860888 | FIBRICOR 35 MG Oral Tablet | PSN | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860884 | fenofibric acid 105 MG Oral Tablet [Fibricor] | SBD | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860888 | fenofibric acid 35 MG Oral Tablet [Fibricor] | SBD | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860880 | fenofibric acid 105 MG Oral Tablet | SCD | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860886 | fenofibric acid 35 MG Oral Tablet | SCD | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860884 | Fibricor (fenofibric acid 105 MG) Oral Tablet | SY | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860888 | Fibricor (fenofibric acid 35 MG) Oral Tablet | SY | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860884 | Fibricor 105 MG Oral Tablet | SY | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
| 860888 | Fibricor 35 MG Oral Tablet | SY | 777b0c6b-cd25-454d-a35b-d2df9b44497f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69916-035-30 | 69916003530 | 30 in 1 BOTTLE, PLASTIC | Historical |