FENOFIBRIC ACID DELAYED-RELEASE
- Product NDC
- 42385-944
- 11-digit product format
- 423850944
- Labeler code
- 42385
- Product ID
- 42385-944_f0e00f9f-65f5-407a-e053-2a95a90a260f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRIC ACID
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA211626
- Marketing category
- ANDA
- Marketing start
- 2020-08-24
- Substance
- FENOFIBRIC ACID
- 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 DELAYED-RELEASE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRIC ACID | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BGF9MN2HU1 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-944-11 | FENOFIBRIC ACID DELAYED-RELEASE | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 3 |
| 42385-944-30 | FENOFIBRIC ACID DELAYED-RELEASE | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
| 42385-944-90 | FENOFIBRIC ACID DELAYED-RELEASE | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-944 | FENOFIBRIC ACID DELAYED-RELEASE (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE FENOFIBRIC ACID DELAYED-RELEASE (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [LAURUS LABS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20221229_302ffbf8-448e-4729-949f-40d457e30ab4.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 |
|---|
| 42385-944-11 | 42385094411 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-11) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 42385-944-30 | 42385094430 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-30) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 42385-944-90 | 42385094490 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-90) | 2020-08-24 | 0000-00-00 | No | No | Current |