Glimepiride
- Product NDC
- 43063-630
- 11-digit product format
- 430630630
- Labeler code
- 43063
- Product ID
- 43063-630_47d267f8-b7ad-6cc7-e063-6294a90a1c0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2007-08-23
- 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 |
|---|
| 43063-630-30 | Glimepiride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 21 |
| 43063-630-90 | Glimepiride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-630 | GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240815_1b3c7d74-f80b-4fb1-8dca-66880af5d3fc.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 |
|---|
| 43063-630-30 | 43063063030 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30) | 30 tablet | 2015-10-29 | 0000-00-00 | No | No | Current |
| 43063-630-90 | 43063063090 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90) | 90 tablet | 2015-10-29 | 0000-00-00 | No | No | Current |