Glyburide and Metformin Hydrochloride
- Product NDC
- 50090-2031
- 11-digit product format
- 500902031
- Labeler code
- 50090
- Product ID
- 50090-2031_4ec075ec-85cf-451e-927a-80ab73d2a2d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2007-11-14
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 2.5; 500 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], 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
- Glyburide and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 2.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC, 786Z46389E |
| Rxcui | 861748, 861753 |
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 |
|---|
| 50090-2031-0 | Glyburide and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 25 |
| 50090-2031-1 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 25 |
| 50090-2031-2 | Glyburide and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-2031 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 22 | Current NDC, Legacy NDC, 3 package rows | 20240805_d87dade1-55fe-4e77-91b9-b642022a2b8a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-2031-0 | 50090203100 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2031-0) | 2015-09-24 | 0000-00-00 | No | No | Current |
| 50090-2031-1 | 50090203101 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2031-1) | 2015-09-24 | 0000-00-00 | No | No | Current |
| 50090-2031-2 | 50090203102 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-2031-2) | 2015-09-24 | 0000-00-00 | No | No | Current |