Prescription drug · ANDA
Dapagliflozin And Metformin Hydrochloride NDC 70748-102
Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70748-102-07 | 70748010207 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-102-07)Marketed from Apr 17, 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, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211579
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 70748-102_deac53e9-671e-4972-b0fa-9fdf2652a682SPL ID deac53e9-671e-4972-b0fa-9fdf2652a682
- 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
N470748010207followed by a unit qualifier and the quantityPackage 70748-0102-07. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 211579
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, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 70748-101 |
| Dapagliflozin And Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 70748-103 |
| Dapagliflozin And Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 70748-104 |