Glimepiride
- Product NDC
- 53217-285
- 11-digit product format
- 532170285
- Labeler code
- 53217
- Product ID
- 53217-285_cca6f5cd-fac6-413d-81e5-6d8447ec119a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA091220
- Marketing category
- ANDA
- Marketing start
- 2015-10-01
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-285-00 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 53217-285-30 | Glimepiride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-285-60 | Glimepiride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-285-90 | Glimepiride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 53217-285-99 | Glimepiride | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-285 | GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 5 package rows | 20170422_9bbfd55a-c88f-48b6-b18f-7d3d83c26158.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-285-00 | 53217028500 | 100 in 1 BOTTLE | Historical |
| 53217-285-30 | 53217028530 | 30 in 1 BOTTLE | Historical |
| 53217-285-60 | 53217028560 | 60 in 1 BOTTLE | Historical |
| 53217-285-90 | 53217028590 | 90 in 1 BOTTLE | Historical |
| 53217-285-99 | 53217028599 | 180 in 1 BOTTLE | Historical |