Glyburide and Metformin Hydrochloride
- Product NDC
- 68788-8634
- 11-digit product format
- 687888634
- Labeler code
- 68788
- Product ID
- 68788-8634_a585cd8a-3d17-48aa-8d80-80d35fb430d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2024-04-16
- 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 and 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 |
|---|
| 68788-8634-1 | Glyburide and Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 68788-8634-3 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 68788-8634-6 | Glyburide and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 68788-8634-8 | Glyburide and Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
| 68788-8634-9 | Glyburide and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8634 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 5 package rows | 20240420_a58ff524-e975-4d51-a896-e869f8ea6624.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8634-1 | 68788863401 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8634-1) | 2024-04-16 | No | No | Historical |
| 68788-8634-3 | 68788863403 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8634-3) | 2024-04-16 | No | No | Historical |
| 68788-8634-6 | 68788863406 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8634-6) | 2024-04-16 | No | No | Historical |
| 68788-8634-8 | 68788863408 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8634-8) | 2024-04-16 | No | No | Historical |
| 68788-8634-9 | 68788863409 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8634-9) | 2024-04-16 | No | No | Historical |