Prescription drug · NDA
Xigduo XR NDC 0310-6260
dapagliflozin and metformin hydrochloride · Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-6260-60 | 00310626060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60)Marketed from Nov 11, 2014 | |
| 0310-6260-95 | 00310626095 | 1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 11, 2014 · Sample package |
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 — 5 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205649
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-6260_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
N400310626060followed by a unit qualifier and the quantityPackage 00310-6260-60. 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 . 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.
Other NDCs under NDA 205649
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 2.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6225 |
| 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 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 |
| dapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-362 |
| dapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-361 |