Glyburide
- Product NDC
- 70518-4035
- 11-digit product format
- 705184035
- Labeler code
- 70518
- Product ID
- 70518-4035_38516eee-640b-10f4-e063-6394a90a21ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203379
- Marketing category
- ANDA
- Marketing start
- 2024-03-11
- Substance
- GLYBURIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC |
| Rxcui | 310537 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4035-0 | Glyburide | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
| 70518-4035-1 | Glyburide | 360 in 1 BOTTLE, PLASTIC | TABLET | 360 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4035 | GLYBURIDE TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20240312_524eec41-37ee-419a-b7a1-d23e888ae6ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4035-0 | 70518403500 | 30 TABLET in 1 BLISTER PACK (70518-4035-0) | 30 tablet | 2024-03-11 | No | No | Current |
| 70518-4035-1 | 70518403501 | 360 TABLET in 1 BOTTLE, PLASTIC (70518-4035-1) | 360 tablet | 2025-06-24 | No | No | Current |