glyburide-metformin hydrochloride
- Product NDC
- 23155-233
- 11-digit product format
- 231550233
- Labeler code
- 23155
- Product ID
- 23155-233_5b65cafb-4e53-4197-a872-c12ffdbc04e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide-metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA079009
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 1.25; 250 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-metformin hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 1.25 mg/1 |
| METFORMIN HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC, 786Z46389E |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-233-01 | glyburide-metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 15 |
| 23155-233-05 | glyburide-metformin hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 15 |
| 23155-233-10 | glyburide-metformin hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-233 | GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 3 package rows | 20240501_b38213bb-d663-4c95-a1b2-96c23ee5be09.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 |
|---|
| 23155-233-01 | 23155023301 | 100 TABLET in 1 BOTTLE (23155-233-01) | 100 tablet | 2024-05-01 | 0000-00-00 | No | No | Current |
| 23155-233-05 | 23155023305 | 500 TABLET in 1 BOTTLE (23155-233-05) | 500 tablet | 2024-05-01 | 0000-00-00 | No | No | Current |
| 23155-233-10 | 23155023310 | 1000 TABLET in 1 BOTTLE (23155-233-10) | 1000 tablet | 2024-05-01 | 0000-00-00 | No | No | Current |