Fenofibric Acid
- Product NDC
- 69973-035
- 11-digit product format
- 699730035
- Labeler code
- 69973
- Product ID
- 69973-035_57620cb7-e168-4a65-a3fc-420bf17d3c58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Halton Laboratories
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 69973-035-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e04e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use fenofibric acid tablets safely and effectively. See full prescribing information for fenofibric acid tablets. Fenofibric Acid Tablets, for oral use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69973-035-30 | Fenofibric Acid | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69973-035-30 | EA - Each | 69973-035 | 9d6a73de-c897-4e39-9917-34e13064dbe2 | 1 | 2016-05-16 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fenofibric Acid | ACTIVE INGREDIENT | BGF9MN2HU1 | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 | |
| Fenofibric Acid | ACTIVE MOIETY | BGF9MN2HU1 | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 | |
| Copovidone K25-31 | INACTIVE INGREDIENT | D9C330MD8B | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRIC ACID TABLET [HALTON LABORATORIES] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860880 | fenofibric acid 105 MG Oral Tablet | PSN | be471aad-d936-48be-8c79-351b56ae9cc7 | 5 |
| 860886 | fenofibric acid 35 MG Oral Tablet | PSN | be471aad-d936-48be-8c79-351b56ae9cc7 | 5 |
| 860880 | fenofibric acid 105 MG Oral Tablet | SCD | be471aad-d936-48be-8c79-351b56ae9cc7 | 5 |
| 860886 | fenofibric acid 35 MG Oral Tablet | SCD | be471aad-d936-48be-8c79-351b56ae9cc7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69973-035-30 | 69973003530 | 30 in 1 BOTTLE, PLASTIC | Historical |