Fenofibrate
- Product NDC
- 68180-388
- 11-digit product format
- 681800388
- Labeler code
- 68180
- Product ID
- 68180-388_e454c5bc-7a0e-4d5e-95fb-ccf812747a3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA090856
- Marketing category
- ANDA
- Marketing start
- 2020-08-01
- Substance
- FENOFIBRATE
- Active strength
- 48 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 table| Ingredient | Strength |
|---|
| FENOFIBRATE | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-388-09 | Fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-388 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20250316_45364845-c3b4-40a1-a677-82202ffaa5ad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-388-09 | 68180038809 | 90 TABLET in 1 BOTTLE (68180-388-09) | 90 tablet | 2020-08-01 | 0000-00-00 | No | No | Current |