Glyburide and Metformin Hydrochloride
- Product NDC
- 71335-0967
- 11-digit product format
- 713350967
- Labeler code
- 71335
- Product ID
- 71335-0967_a65ff15e-5686-4b04-87fa-234c40271d6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077870
- Marketing category
- ANDA
- Marketing start
- 2007-11-14
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5; 500 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glyburide and Metformin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYBURIDE | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | SX6K58TVWC, 786Z46389E |
| Rxcui | 861753 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-0967-1 | Glyburide and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 | |
| 71335-0967-3 | Glyburide and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 7 | |
| 71335-0967-4 | Glyburide and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 | |
| 71335-0967-5 | Glyburide and Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 7 | |
| 71335-0967-6 | Glyburide and Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 7 | |
| 71335-0967-7 | Glyburide and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | 7 | |
| 71335-0967-8 | Glyburide and Metformin Hydrochloride | 25 in 1 BOTTLE | TABLET, FILM COATED | 25 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0967 | GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 7 package rows | 20240601_8f2951ab-20c3-4216-b250-4c6a62d32203.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861753 | glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet | PSN | 8f2951ab-20c3-4216-b250-4c6a62d32203 | 7 |
| 861753 | glyburide 5 MG / metformin hydrochloride 500 MG Oral Tablet | SCD | 8f2951ab-20c3-4216-b250-4c6a62d32203 | 7 |
| 861753 | glyburide 5 MG / metformin HCl 500 MG Oral Tablet | SY | 8f2951ab-20c3-4216-b250-4c6a62d32203 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-0967-1 | 71335096701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0967-1) | 2018-10-15 | 0000-00-00 | No | No | Current |
| 71335-0967-3 | 71335096703 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0967-3) | 2018-10-15 | 0000-00-00 | No | No | Current |
| 71335-0967-4 | 71335096704 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0967-4) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-0967-5 | 71335096705 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0967-5) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-0967-6 | 71335096706 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0967-6) | 2018-10-11 | 0000-00-00 | No | No | Current |
| 71335-0967-7 | 71335096707 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0967-7) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-0967-8 | 71335096708 | 25 TABLET, FILM COATED in 1 BOTTLE (71335-0967-8) | 2024-05-30 | 0000-00-00 | No | No | Current |