Glimepiride
- Product NDC
- 51655-383
- 11-digit product format
- 516550383
- Labeler code
- 51655
- Product ID
- 51655-383_4b429739-4ecc-4f6f-e063-6294a90aaa11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2022-09-07
- Substance
- GLIMEPIRIDE
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6KY687524K |
| Rxcui | 199246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-383-26 | Glimepiride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
| 51655-383-52 | Glimepiride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-383 | GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230316_f2f2d6da-eb40-4290-e053-2a95a90a6ca0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-383-26 | 51655038326 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-383-26) | 90 tablet | 2023-01-20 | No | No | Historical |
| 51655-383-52 | 51655038352 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-383-52) | 30 tablet | 2022-09-07 | No | No | Historical |