Prescription drug · ANDA
Dapagliflozin and Metformin Hydrochloride NDC 84677-021
Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-021-30 | 84677002130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84677-021-30)Marketed from Mar 16, 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 — 10 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211491
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 84677-021_54026404-8dfd-12f8-e063-6394a90a9a60SPL ID 54026404-8dfd-12f8-e063-6394a90a9a60SPL set ID 54027b70-53e7-3710-e063-6394a90aa04cRxCUI 1593058, 1593068, 1593070UNII 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
N484677002130followed by a unit qualifier and the quantityPackage 84677-0021-30. 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 a combination of dapagliflozin and metformin hydrochloride (HCl) 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 tablets, 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 hea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211491
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 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-028 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-027 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-026 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-020 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-022 |