Glimepiride
- Product NDC
- 16571-775
- 11-digit product format
- 165710775
- Labeler code
- 16571
- Product ID
- 16571-775_f06a97e3-4349-4df3-87de-4479c1ed69bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA202759
- Marketing category
- ANDA
- Marketing start
- 2012-06-29
- Substance
- GLIMEPIRIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2027-12-31
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 |
|---|
| 16571-775-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 16571-775-50 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-775 | GLIMEPIRIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231101_48ada723-8144-497d-afd6-a8c52a1dd3ff.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 |
|---|
| 16571-775-01 | 16571077501 | 100 TABLET in 1 BOTTLE (16571-775-01) | 100 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |
| 16571-775-50 | 16571077550 | 500 TABLET in 1 BOTTLE (16571-775-50) | 500 tablet | 2012-06-29 | 0000-00-00 | No | No | Current |