Gemfibrozil
- Product NDC
- 16571-784
- 11-digit product format
- 165710784
- Labeler code
- 16571
- Product ID
- 16571-784_3e8381a4-86bf-4b7b-8631-ba616a85f3ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemfibrozil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 310459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-784-06 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 16571-784-50 | Gemfibrozil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-784 | GEMFIBROZIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240524_8f36abfa-dc52-4c99-8a4a-b0cb80c3249a.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 |
|---|
| 16571-784-06 | 16571078406 | 60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06) | 2015-09-16 | 0000-00-00 | No | No | Current |
| 16571-784-50 | 16571078450 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-784-50) | 2015-09-16 | 0000-00-00 | No | No | Current |