glyburide-metformin hydrochloride
- Product NDC
- 50090-7514
- 11-digit product format
- 500907514
- Labeler code
- 50090
- Product ID
- 50090-7514_3c0006ae-e263-40a5-a8bc-ab5a20b7858d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide-metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA079009
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 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-metformin hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC, 786Z46389E |
| Rxcui | 861753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7514-0 | glyburide-metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 50090-7514-2 | glyburide-metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 50090-7514-3 | glyburide-metformin hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 50090-7514-4 | glyburide-metformin hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7514 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 2 | Current NDC, 4 package rows | 20250309_f43c087a-7135-4a79-8463-fe5e9319da91.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 |
|---|
| 50090-7514-0 | 50090751400 | 60 TABLET in 1 BOTTLE (50090-7514-0) | 60 tablet | 2025-03-03 | No | No | Historical |
| 50090-7514-2 | 50090751402 | 100 TABLET in 1 BOTTLE (50090-7514-2) | 100 tablet | 2025-03-03 | No | No | Historical |
| 50090-7514-3 | 50090751403 | 90 TABLET in 1 BOTTLE (50090-7514-3) | 90 tablet | 2025-03-03 | No | No | Historical |
| 50090-7514-4 | 50090751404 | 180 TABLET in 1 BOTTLE (50090-7514-4) | 180 tablet | 2025-03-03 | No | No | Historical |