Dapagliflozin NDC 60505-4912

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4912Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4912Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
60505-4912-3	60505491203	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-4912-3)Marketed from Apr 8, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211523
Marketing start: Apr 8, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 60505-4912_4f19d2f5-0d0c-0e1b-e063-6394a90a2898SPL ID 4f19d2f5-0d0c-0e1b-e063-6394a90a2898SPL set ID bd9766c5-104f-4636-897d-b6c92eb94f18RxCUI 1488569, 1488574UNII 1ULL0QJ8UC
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

N460505491203 followed by a unit qualifier and the quantity

Package 60505-4912-03. 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 Apr 10, 2026.

Indications (excerpt from the label)

Dapagliflozin tablets are 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 are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. Dapagliflozin tablets are 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 are likely t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211523

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211523
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin	Dapagliflozin 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4911