glyburide and metformin hydrochloride
- Product NDC
- 68788-6915
- 11-digit product format
- 687886915
- Labeler code
- 68788
- Product ID
- 68788-6915_b4c116bb-be6a-423a-a58a-e2cdc5cdc09c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide and metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206748
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 68788-6915-1 | glyburide and metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68788-6915-3 | glyburide and metformin hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68788-6915-6 | glyburide and metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68788-6915-8 | glyburide and metformin hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 5 |
| 68788-6915-9 | glyburide and metformin hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-6915 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 5 | Legacy NDC, 5 package rows | 20200609_5de677d1-f3eb-4019-9e6f-b1f4209f7bb7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-6915-1 | 68788691501 | 100 TABLET in 1 BOTTLE (68788-6915-1) | 100 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68788-6915-3 | 68788691503 | 30 TABLET in 1 BOTTLE (68788-6915-3) | 30 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68788-6915-6 | 68788691506 | 60 TABLET in 1 BOTTLE (68788-6915-6) | 60 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68788-6915-8 | 68788691508 | 120 TABLET in 1 BOTTLE (68788-6915-8) | 120 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68788-6915-9 | 68788691509 | 90 TABLET in 1 BOTTLE (68788-6915-9) | 90 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |