Glimepiride
- Product NDC
- 0615-8334
- 11-digit product format
- 006158334
- Labeler code
- 0615
- Product ID
- 0615-8334_18f8ad9b-20d5-47ea-ad3a-9b2a7e3a4dd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA091220
- Marketing category
- ANDA
- Marketing start
- 2013-06-13
- Substance
- GLIMEPIRIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLIMEPIRIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199245, 199246, 199247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8334-39 | Glimepiride | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8334 | GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | Current NDC, Legacy NDC, 1 package rows | 20200505_669a67c2-2f97-4b7e-8bba-83a015e0fa94.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 |
|---|
| 0615-8334-39 | 00615833439 | 30 TABLET in 1 BLISTER PACK (0615-8334-39) | 30 tablet | 2020-04-13 | 0000-00-00 | No | No | Current |