Glyburide
- Product NDC
- 0093-8035
- 11-digit product format
- 000938035
- Labeler code
- 0093
- Product ID
- 0093-8035_d734cd0e-df7b-40a2-a511-fc04308a764d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA074686
- Marketing category
- ANDA
- Marketing start
- 1999-05-11
- Marketing end
- 2027-01-31
- Substance
- GLYBURIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glyburide
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYBURIDE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SX6K58TVWC |
| Rxcui | 310536, 310539, 314000 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8035-01 | Glyburide | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 0093-8035-05 | Glyburide | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC] | 11 | |
| GLYBURIDE | ACTIVE INGREDIENT | SX6K58TVWC | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| GLYBURIDE | ACTIVE MOIETY | SX6K58TVWC | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GLYBURIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8035 | GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20230913_e84c0dfc-a4e9-4c89-b6ea-45732eb412f5.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 |
|---|
| 0093-8035-01 | 00093803501 | 100 TABLET in 1 BOTTLE (0093-8035-01) | 100 tablet | 1999-05-11 | 2027-01-31 | No | No | Current |
| 0093-8035-05 | 00093803505 | 500 TABLET in 1 BOTTLE (0093-8035-05) | 500 tablet | 1999-05-11 | 2027-01-31 | No | No | Current |