Fenofibric acid
- Product NDC
- 68180-128
- 11-digit product format
- 681800128
- Labeler code
- 68180
- Product ID
- 68180-128_574221bf-1643-4dd4-8ac6-29f387ce5eaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric acid
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA200750
- Marketing category
- ANDA
- Marketing start
- 2013-12-04
- Substance
- CHOLINE FENOFIBRATE
- Active strength
- 45 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
- Fenofibric acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHOLINE FENOFIBRATE | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BMH7IZT98 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-128-01 | Fenofibric acid | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 12 |
| 68180-128-02 | Fenofibric acid | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | | 12 |
| 68180-128-09 | Fenofibric acid | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CHOLINE FENOFIBRATE | ACTIVE INGREDIENT | 4BMH7IZT98 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-128 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20231216_b9a3f97c-9e31-4a5f-822f-c9d45e394493.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-128-01 | 68180012801 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-01) | 2013-12-04 | 0000-00-00 | No | No | Current |
| 68180-128-02 | 68180012802 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-02) | 2013-12-04 | 0000-00-00 | No | No | Current |
| 68180-128-09 | 68180012809 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-09) | 2013-12-04 | 0000-00-00 | No | No | Current |