NDC 0597-0295 – Synjardy XR
Empagliflozin 25 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Extended Release · Oral
Product NDC0597-0295
Product details
- Brand name
- Synjardy XR
- Generic name
- Empagliflozin, metformin hydrochloride
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- NDA · NDA208658
- Marketed since
- December 10, 2016
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
Active ingredients
- Empagliflozin 25 mg/1
- Metformin Hydrochloride 1000 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0295-61 sample | 1 BOTTLE in 1 CARTON (0597-0295-61) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE | Dec 10, 2016 |
| 0597-0295-78 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-78) | Dec 10, 2016 |
| 0597-0295-88 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-88) | Dec 10, 2016 |
Recalls mentioning this NDC
- D-0458-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0459-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Synjardy products
- 0597-0280 Empagliflozin 10 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Extended Release · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0290 Empagliflozin 5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Extended Release · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0300 Empagliflozin 12.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet, Extended Release · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0159 Empagliflozin 5 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0168 Empagliflozin 12.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0175 Empagliflozin 5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet · Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0180 Empagliflozin 12.5 mg/1; Metformin Hydrochloride 500 mg/1 · Tablet · Boehringer Ingelheim Pharmaceuticals, Inc.