dapagliflozin NDC 33342-586

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-586Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0586Add 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
33342-586-07	33342058607	30 TABLET in 1 BOTTLE (33342-586-07)Marketed from Apr 6, 2026
33342-586-10	33342058610	90 TABLET in 1 BOTTLE (33342-586-10)Marketed from Apr 6, 2026
33342-586-56	33342058656	10 BLISTER PACK in 1 CARTON (33342-586-56) / 14 TABLET in 1 BLISTER PACK (33342-586-66)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
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211506
Marketing start: Apr 6, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 33342-586_31e8764a-d64a-4282-8072-9fd6b7c24ea4SPL ID 31e8764a-d64a-4282-8072-9fd6b7c24ea4SPL set ID 91373924-66dc-4277-aaf2-8536e81a0e4dRxCUI 1488569, 1488574UNII 1ULL0QJ8UCUPC 0333342586070, 0333342586100, 0333342585073, 0333342585103
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

N433342058607 followed by a unit qualifier and the quantity

Package 33342-0586-07. 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

Current FDA label (SPL), effective Jul 9, 2026.

Indications (excerpt from the label)

Dapagliflozin is indicated: •To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )] . • Dapagliflozin 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 is likely to be ineffective in this setting based upon its mec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211506

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

FDA NDC Directory listings under ANDA 211506
Product	Strength	Form · route	Labeler	Product NDC
dapagliflozin	Dapagliflozin 5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-585
dapagliflozin	Dapagliflozin 10 mg/1	TabletOral	Redpharm Drug	67296-2334