Glyburide
- Product NDC
- 70518-3504
- 11-digit product format
- 705183504
- Labeler code
- 70518
- Product ID
- 70518-3504_51dff362-914b-e05f-e063-6294a90aad9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203379
- Marketing category
- ANDA
- Marketing start
- 2022-08-31
- Substance
- GLYBURIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC |
| Rxcui | 310534 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3504-0 | Glyburide | 30 in 1 BLISTER PACK | TABLET | 30 | | 8 |
| 70518-3504-1 | Glyburide | 30 in 1 BLISTER PACK | TABLET | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3504 | GLYBURIDE TABLET [REMEDYREPACK INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240213_e23b9a3b-0184-4d1c-8e2c-668697a6da87.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 |
|---|
| 70518-3504-0 | 70518350400 | 30 TABLET in 1 BLISTER PACK (70518-3504-0) | 30 tablet | 2022-08-31 | 0000-00-00 | No | No | Current |
| 70518-3504-1 | 70518350401 | 30 TABLET in 1 BLISTER PACK (70518-3504-1) | 30 tablet | 2024-02-12 | | No | No | Current |