Glyburide
- Product NDC
- 42254-090
- 11-digit product format
- 422540090
- Labeler code
- 42254
- Product ID
- 42254-090_58200048-a278-4f9a-b705-affc358537fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bea938a6-c880-985b-d27b-b59b0d8b5a77 | Product name | 3 | 20170626 |
| 0600b0d3-c32a-40bb-8d87-3a2934cd8f2f | Product name | 1 | 20170616 |
| 64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6 | Product name | 2 | 20160609 |
| 5a2baaae-1290-c05e-207f-b1367e9eb46a | Product name | 2 | 20151005 |
| b044018d-bcdc-e68d-63da-1ad6886aea64 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-090-60 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3dcd-c013-e053-90daa90a1393 | Glyburide Tablets, USP 5 mg For Oral Use |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-090-60 | Glyburide | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-090-60 | EA - Each | 42254-090 | 865cc333-4e92-41a4-95d5-c64663e4cd7b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310537 | glyBURIDE 5 MG Oral Tablet | PSN | 58200048-a278-4f9a-b705-affc358537fb | 1 |
| 310537 | glyburide 5 MG Oral Tablet | SCD | 58200048-a278-4f9a-b705-affc358537fb | 1 |
| 310537 | glibenclamide 5 MG Oral Tablet | SY | 58200048-a278-4f9a-b705-affc358537fb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-090-60 | 42254009060 | 60 in 1 BOTTLE | Historical |