GLYBURIDE
- Product NDC
- 53002-4170
- 11-digit product format
- 530024170
- Labeler code
- 53002
- Product ID
- 53002-4170_d9161324-f19d-484d-8d54-51436e6d2126
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYBURIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090937
- Marketing category
- ANDA
- Marketing start
- 2010-10-05
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-4170-0 | 2025-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-6 | 2025-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-0 | 2023-06-07 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-3 | 2023-06-07 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-6 | 2023-06-07 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
| 53002-4170-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-a067-0266-e053-dadaa90a7c1a | Glyburide Tablets, USP 1.25, 2.5, and 5 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4170-0 | GLYBURIDE | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 53002-4170-3 | GLYBURIDE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 53002-4170-6 | GLYBURIDE | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4170 | GLYBURIDE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20230609_172ad55b-f2d2-4764-bcf6-8c209dd4b4a0.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 |
|---|
| 53002-4170-0 | 53002417000 | 100 TABLET in 1 BOTTLE (53002-4170-0) | 100 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-4170-3 | 53002417003 | 30 TABLET in 1 BOTTLE (53002-4170-3) | 30 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-4170-6 | 53002417006 | 60 TABLET in 1 BOTTLE (53002-4170-6) | 60 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |