Glyburide
- Product NDC
- 43353-659
- 11-digit product format
- 433530659
- Labeler code
- 43353
- Product ID
- 43353-659_450c5c16-46d8-4867-8f8b-c84dd8515761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA017532
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1984-05-01
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 43353-659-60 | Glyburide | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 3 |
| 43353-659-80 | Glyburide | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| glyburide | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| glyburide | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| calcium phosphate, dibasic, anhydrous | INACTIVE INGREDIENT | L11K75P92J | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C Blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| sodium alginate | INACTIVE INGREDIENT | C269C4G2ZQ | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-659 | GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 2 package rows | 20191224_820400e2-d340-416d-9015-c56357780362.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 |
|---|
| 43353-659-60 | 43353065960 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-659-60) | 90 tablet | 2010-09-24 | 0000-00-00 | No | No | Current |
| 43353-659-80 | 43353065980 | 180 TABLET in 1 BOTTLE, PLASTIC (43353-659-80) | 180 tablet | 2010-09-24 | 0000-00-00 | No | No | Current |