Prescription drug · ANDA
Dapagliflozin and Metformin hydrochloride NDC 59651-155
Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-155-04 | 59651015504 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-04)Marketed from Apr 6, 2026 | |
| 59651-155-30 | 59651015530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-30)Marketed from Apr 6, 2026 | |
| 59651-155-60 | 59651015560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-60)Marketed from Apr 6, 2026 |
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)
- Dapagliflozin and Metformin hydrochloride
- Generic name (nonproprietary)
- dapagliflozin and metformin hydrochloride
- Active ingredients
- Dapagliflozin — 5 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211489
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-155_513bdf9f-774c-4f7f-935a-54d3885e80a4SPL ID 513bdf9f-774c-4f7f-935a-54d3885e80a4SPL set ID 513bdf9f-774c-4f7f-935a-54d3885e80a4RxCUI 1593058, 1593068, 1593070, 1593072UNII 786Z46389E, 1ULL0QJ8UC
- Pharmacologic class
- Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
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
N459651015504followed by a unit qualifier and the quantityPackage 59651-0155-04. 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)
Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211489
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 |
|---|---|---|---|---|
| Dapagliflozin and Metformin hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-154 |
| Dapagliflozin and Metformin hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-156 |
| Dapagliflozin and Metformin hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-157 |