Prescription drug · ANDA
Dapagliflozin NDC 67877-609
Dapagliflozin 10 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-609-05 | 67877060905 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-609-05)Marketed from Apr 6, 2026 | |
| 67877-609-30 | 67877060930 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-609-30)Marketed from Apr 6, 2026 | |
| 67877-609-33 | 67877060933 | 1 BLISTER PACK in 1 CARTON (67877-609-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 6, 2026 | |
| 67877-609-90 | 67877060990 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-609-90)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
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211545
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-609_4cb873fb-8492-48d2-8dd7-bc86ed72e20bSPL ID 4cb873fb-8492-48d2-8dd7-bc86ed72e20bSPL set ID b6b8a10c-64c3-4856-8961-d72d68784f5dRxCUI 1488569, 1488574UNII 1ULL0QJ8UCUPC 0367877609058
- Pharmacologic class
- 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
N467877060905followed by a unit qualifier and the quantityPackage 67877-0609-05. 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 .
Indications (excerpt from the label)
Dapagliflozin tablets is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )]. Dapagliflozin tablets is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets is likely to b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211545
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 | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-608 |