GLYBURIDE
- Product NDC
- 50090-5776
- 11-digit product format
- 500905776
- Labeler code
- 50090
- Product ID
- 50090-5776_e847f32b-6c85-4e8d-8733-3b0b850016eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYBURIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090937
- Marketing category
- ANDA
- Marketing start
- 2010-10-05
- Substance
- GLYBURIDE
- Active strength
- 2.5 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
- GLYBURIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC |
| Rxcui | 310534 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5776-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-cb37-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 50090-5776-2 | 2023-02-06 | C162847 | 48780-1 | f386c649-cb37-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 50090-5776-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-cb37-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 50090-5776-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-cb37-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5776-0 | GLYBURIDE | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 50090-5776-2 | GLYBURIDE | 200 in 1 BOTTLE | TABLET | 200 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5776 | GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231204_7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd.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 |
|---|
| 50090-5776-0 | 50090577600 | 30 TABLET in 1 BOTTLE (50090-5776-0) | 30 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 50090-5776-2 | 50090577602 | 200 TABLET in 1 BOTTLE (50090-5776-2) | 200 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |