glyburide-metformin hydrochloride
- Product NDC
- 71335-2508
- 11-digit product format
- 713352508
- Labeler code
- 71335
- Product ID
- 71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide-metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- glyburide-metformin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| GLYBURIDE | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | SX6K58TVWC, 786Z46389E |
| Rxcui | 861753 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| SX6K58TVWC | GLYBURIDE | 10238-21-8 | GLYBURIDE |
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2508-1 | 71335250801 | 30 TABLET in 1 BOTTLE (71335-2508-1) | 30 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-3 | 71335250803 | 60 TABLET in 1 BOTTLE (71335-2508-3) | 60 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-4 | 71335250804 | 90 TABLET in 1 BOTTLE (71335-2508-4) | 90 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-5 | 71335250805 | 120 TABLET in 1 BOTTLE (71335-2508-5) | 120 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-6 | 71335250806 | 100 TABLET in 1 BOTTLE (71335-2508-6) | 100 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-7 | 71335250807 | 180 TABLET in 1 BOTTLE (71335-2508-7) | 180 tablet | 2024-10-21 | No | No | Current |
| 71335-2508-8 | 71335250808 | 25 TABLET in 1 BOTTLE (71335-2508-8) | 25 tablet | 2024-10-21 | No | No | Current |