Gemfibrozil
- Product NDC
- 63187-772
- 11-digit product format
- 631870772
- Labeler code
- 63187
- Product ID
- 63187-772_e7d02874-58bd-44fb-afdf-41b8f82a93e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-07-08
- 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 |
|---|
| 63187-772-30 | Gemfibrozil | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 63187-772-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 63187-772-72 | Gemfibrozil | 120 in 1 BOTTLE | TABLET | 120 | | 5 |
| 63187-772-78 | Gemfibrozil | 180 in 1 BOTTLE | TABLET | 180 | | 5 |
| 63187-772-90 | Gemfibrozil | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-772 | GEMFIBROZIL TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 5 package rows | 20220504_7dbd38ab-7965-463f-9f8e-70efa8e071fb.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 |
|---|
| 63187-772-30 | 63187077230 | 30 TABLET in 1 BOTTLE (63187-772-30) | 30 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-772-60 | 63187077260 | 60 TABLET in 1 BOTTLE (63187-772-60) | 60 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-772-72 | 63187077272 | 120 TABLET in 1 BOTTLE (63187-772-72) | 120 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-772-78 | 63187077278 | 180 TABLET in 1 BOTTLE (63187-772-78) | 180 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-772-90 | 63187077290 | 90 TABLET in 1 BOTTLE (63187-772-90) | 90 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |