NDC 0310-6260 – Xigduo Xr
Dapagliflozin Propanediol 5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC0310-6260
Product details
- Brand name
- Xigduo Xr
- Generic name
- Dapagliflozin and metformin hydrochloride
- Labeler
- AstraZeneca Pharmaceuticals LP
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- NDA · NDA205649
- Marketed since
- October 29, 2014
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
Active ingredients
- Dapagliflozin Propanediol 5 mg/1
- Metformin Hydrochloride 1000 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0310-6260-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60) | Nov 11, 2014 |
| 0310-6260-95 sample | 1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | Nov 11, 2014 |
Recalls mentioning this NDC
- D-0436-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0435-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Xigduo products
- 0310-6225 Dapagliflozin Propanediol 2.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · AstraZeneca Pharmaceuticals LP
- 0310-6250 Dapagliflozin Propanediol 5 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet, Film Coated, Extended Release · AstraZeneca Pharmaceuticals LP
- 0310-6270 Dapagliflozin Propanediol 10 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet, Film Coated, Extended Release · AstraZeneca Pharmaceuticals LP
- 0310-6280 Dapagliflozin Propanediol 10 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Film Coated, Extended Release · AstraZeneca Pharmaceuticals LP