Glyburide and Metformin Hydrochloride
- Product NDC
- 68071-4718
- 11-digit product format
- 680714718
- Labeler code
- 68071
- Product ID
- 68071-4718_1ab9df7f-6510-2ace-e063-6394a90a3bde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2007-11-14
- 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 and Metformin Hydrochloride
- Listing expiration
- 2026-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4718-3 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4718 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240614_7facb5ac-c1d5-43b4-e053-2991aa0a2a7b.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 |
|---|
| 68071-4718-3 | 68071471803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4718-3) | 2019-01-17 | 0000-00-00 | No | No | Current |