glyburide-metformin hydrochloride
- Product NDC
- 71335-2694
- 11-digit product format
- 713352694
- Labeler code
- 71335
- Product ID
- 71335-2694_3520e643-2331-47fa-bea4-5206e8e13f22
- 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
- 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
- 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 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2694-1 | glyburide-metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 71335-2694-2 | glyburide-metformin hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71335-2694-3 | glyburide-metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71335-2694-4 | glyburide-metformin hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 71335-2694-5 | glyburide-metformin hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2694-1 | 71335269401 | 100 TABLET in 1 BOTTLE (71335-2694-1) | 100 tablet | 2025-09-24 | No | No | Historical |
| 71335-2694-2 | 71335269402 | 30 TABLET in 1 BOTTLE (71335-2694-2) | 30 tablet | 2025-09-24 | No | No | Historical |
| 71335-2694-3 | 71335269403 | 60 TABLET in 1 BOTTLE (71335-2694-3) | 60 tablet | 2025-09-24 | No | No | Historical |
| 71335-2694-4 | 71335269404 | 90 TABLET in 1 BOTTLE (71335-2694-4) | 90 tablet | 2025-09-24 | No | No | Historical |
| 71335-2694-5 | 71335269405 | 180 TABLET in 1 BOTTLE (71335-2694-5) | 180 tablet | 2025-09-24 | No | No | Historical |