NDC 0597-0168 – Synjardy
Empagliflozin 12.5 mg/1; Metformin Hydrochloride 1000 mg/1 · Tablet · Oral
Product NDC0597-0168
Product details
- Brand name
- Synjardy
- Generic name
- Empagliflozin and metformin hydrochloride
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- NDA · NDA206111
- Marketed since
- August 26, 2015
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
Active ingredients
- Empagliflozin 12.5 mg/1
- Metformin Hydrochloride 1000 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0597-0168-18 | 180 TABLET in 1 BOTTLE (0597-0168-18) | Sep 12, 2015 |
| 0597-0168-60 | 60 TABLET in 1 BOTTLE (0597-0168-60) | Sep 12, 2015 |
| 0597-0168-66 | 1 BOTTLE in 1 CARTON (0597-0168-66) / 14 TABLET in 1 BOTTLE | Sep 12, 2015 |
Recalls mentioning this NDC
- D-0456-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-1217-2018 Oct 3, 2018 · Class II
Cross Contamination With Other Products:
Other Synjardy products
- 0597-0159 Empagliflozin 5 mg/1; Metformin Hydrochloride 500 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.
- 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.
- 0597-0295 Empagliflozin 25 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.