Dapagliflozin And Metformin Hydrochloride NDC 72205-434

NDC codes

FDA NDC Directory

Product NDC (as listed)72205-434Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72205-0434Add 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
72205-434-01	72205043401	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-434-01)Marketed from Apr 9, 2026
72205-434-02	72205043402	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-434-02)Marketed from Apr 9, 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 — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Novadoz Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211479
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 72205-434_4f890458-be94-4baf-b606-83a097e1e23eSPL ID 4f890458-be94-4baf-b606-83a097e1e23eSPL set ID 4f890458-be94-4baf-b606-83a097e1e23eRxCUI 1593058, 1593068, 1593070, 1593072UNII 786Z46389E, 1ULL0QJ8UCUPC 0372205437036, 0372205437029, 0372205435018, 0372205437012, 0372205435032, 0372205436015, 0372205434011, 0372205434028, 0372205436022, 0372205435025
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

N472205043401 followed by a unit qualifier and the quantity

Package 72205-0434-01. 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 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Dapagliflozin and metformin HCl 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 HCl 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 heart failure visit in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211479

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

FDA NDC Directory listings under ANDA 211479
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	Novadoz Pharmaceuticals LLC	72205-437
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Novadoz Pharmaceuticals LLC	72205-435
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Novadoz Pharmaceuticals LLC	72205-436