What is NDC 0310-6225?

0310-6225 is the product NDC for Xigduo XR, Dapagliflozin propanediol 2.5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Xigduo XR (Dapagliflozin and metformin hydrochloride).

What is the active ingredient?

Dapagliflozin propanediol, Metformin hydrochloride.

AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xigduo XR?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xigduo XR NDC 0310-6225 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-6225Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-6225Add 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
0310-6225-60	0031062256000310622560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6225-60)Marketed from Jan 15, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Xigduo XRSuffix: XR
Generic name (nonproprietary): dapagliflozin and metformin hydrochloride
Active ingredients: Dapagliflozin propanediol — 2.5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: AstraZeneca Pharmaceuticals LPNDC labeler code 0310
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205649
Marketing start: Oct 29, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 0310-6225_d3afc286-b96b-4fbd-b4bd-486a3f24e2f4SPL ID d3afc286-b96b-4fbd-b4bd-486a3f24e2f4SPL set ID ac8a0f7b-9f69-4495-abbc-3a47cd75a859RxCUI 1593058, 1593068, 1593070, 1593072, 1593775, 1593831, 1593833, 1593835, 1940496, 1940498UNII 786Z46389E, 887K2391VH
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

N400310622560 followed by a unit qualifier and the quantity

Package 00310-6225-60. 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 Aug 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end‑stage kidney disease, (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. • Hospitalization for heart failure i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0310-6225

What is NDC 0310-6225?: 0310-6225 is the product NDC for Xigduo XR, Dapagliflozin propanediol 2.5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xigduo XR (Dapagliflozin and metformin hydrochloride).
What is the active ingredient?: Dapagliflozin propanediol, Metformin hydrochloride.
Who is the labeler?: AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xigduo XR?: 4 other product NDCs are listed under this name. See all Xigduo XR NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Xigduo XR NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6250	00310-6250-30
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6260	00310-6260-6000310-6260-95
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6270	00310-6270-30
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6280	00310-6280-3000310-6280-95

Other NDCs under NDA 205649

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

FDA NDC Directory listings under NDA 205649
Product	Strength	Form · route	Labeler	Product NDC
dapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Prasco Laboratories	66993-361
dapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Prasco Laboratories	66993-362
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6250
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6260
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6270
Xigduo XRdapagliflozin and metformin hydrochloride	Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	AstraZeneca Pharmaceuticals LP	0310-6280