Prescription drug · ANDA
glyburide and metformin hydrochloride NDC 65841-826
Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-826-01 | 65841082601 | 100 TABLET in 1 BOTTLE (65841-826-01)Marketed from Apr 7, 2016 | |
| 65841-826-05 | 65841082605 | 500 TABLET in 1 BOTTLE (65841-826-05)Marketed from Apr 7, 2016 | |
| 65841-826-06 | 65841082606 | 30 TABLET in 1 BOTTLE (65841-826-06)Marketed from Apr 7, 2016 | |
| 65841-826-10 | 65841082610 | 1000 TABLET in 1 BOTTLE (65841-826-10)Marketed from Apr 7, 2016 | |
| 65841-826-16 | 65841082616 | 90 TABLET in 1 BOTTLE (65841-826-16)Marketed from Apr 7, 2016 | |
| 65841-826-77 | 65841082677 | 10 BLISTER PACK in 1 CARTON (65841-826-77) / 10 TABLET in 1 BLISTER PACK (65841-826-30)Marketed from Apr 7, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- glyburide and metformin hydrochloride
- Generic name (nonproprietary)
- glyburide and metformin hydrochloride
- Active ingredients
- Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206748
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
- Identifiers
- Product ID 65841-826_99ca3856-ca2b-4a2d-b1a1-bd70f8f740b4SPL ID 99ca3856-ca2b-4a2d-b1a1-bd70f8f740b4SPL set ID df752bd4-e197-40a4-a01b-d48ba2c10516RxCUI 861743, 861748, 861753UNII 786Z46389E, SX6K58TVWC
- Pharmacologic class
- Biguanide; Sulfonylurea
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465841082601followed by a unit qualifier and the quantityPackage 65841-0826-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206748
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| glyburide and metformin hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-653 |
| glyburide and metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-654 |
| glyburide and metformin hydrochloride | Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-655 |
| glyburide and metformin hydrochloride | Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-824 |
| glyburide and metformin hydrochloride | Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-825 |