Dapagliflozin and Metformin Hydrochloride NDC 33342-408

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-408Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0408Add 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
33342-408-06	33342040806	3 BLISTER PACK in 1 CARTON (33342-408-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-408-66)Marketed from Apr 6, 2026
33342-408-07	33342040807	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-07)Marketed from Apr 6, 2026
33342-408-09	33342040809	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-09)Marketed from Apr 6, 2026
33342-408-10	33342040810	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-10)Marketed from Apr 6, 2026
33342-408-15	33342040815	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-15)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 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: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211559
Marketing start: Apr 6, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 33342-408_237ce7d1-f375-4c14-971d-a682fdccd6bfSPL ID 237ce7d1-f375-4c14-971d-a682fdccd6bf
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

N433342040806 followed by a unit qualifier and the quantity

Package 33342-0408-06. 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 211559

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

FDA NDC Directory listings under ANDA 211559
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-407
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-406
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-409