Glyburide
- Product NDC
- 68071-3452
- 11-digit product format
- 680713452
- Labeler code
- 68071
- Product ID
- 68071-3452_48860991-6561-7756-e063-6394a90a7d01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA203379
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- Substance
- GLYBURIDE
- Active strength
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC |
| Rxcui | 310537 |
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 |
|---|
| 68071-3452-3 | Glyburide | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 68071-3452-6 | Glyburide | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3452 | GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 2 package rows | 20230707_ffd31d06-6011-34e2-e053-6394a90a437f.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 |
|---|
| 68071-3452-3 | 68071345203 | 30 TABLET in 1 BOTTLE (68071-3452-3) | 30 tablet | 2023-07-06 | No | No | Current |
| 68071-3452-6 | 68071345206 | 60 TABLET in 1 BOTTLE (68071-3452-6) | 60 tablet | 2026-01-16 | No | No | Current |