Glyburide and Metformin Hydrochloride
- Product NDC
- 50090-0887
- 11-digit product format
- 500900887
- Labeler code
- 50090
- Product ID
- 50090-0887_0797d374-f582-4573-8a17-8d55185be64d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2007-11-14
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0887-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-1 | 2023-02-06 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-2 | 2023-02-06 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-3 | 2023-02-06 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
| 50090-0887-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-c965-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0887-0 | Glyburide and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
| 50090-0887-1 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 50090-0887-2 | Glyburide and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 10 |
| 50090-0887-3 | Glyburide and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0887 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 4 package rows | 20230207_ea6a2324-486d-4c7f-88ec-2b4abf5dc5b4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-0887-0 | 50090088700 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0887-1 | 50090088701 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1) | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-0887-2 | 50090088702 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-0887-2) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0887-3 | 50090088703 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-0887-3) | 2019-10-09 | 0000-00-00 | No | No | Current |