Prescription drug · NDA
Synjardy XR (Empagliflozin, metformin hydrochloride) NDC 0597-0280
Empagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Extended release · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0280-73 | 00597028073 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-73)Marketed from Dec 10, 2016 | |
| 0597-0280-90 | 00597028090 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-90)Marketed from Dec 10, 2016 |
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)
- Synjardy XRSuffix: XR
- Generic name (nonproprietary)
- empagliflozin, metformin hydrochloride
- Active ingredients
- Empagliflozin — 10 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208658
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0280_92a5c89e-3862-4a40-aee0-9134938f9629SPL ID 92a5c89e-3862-4a40-aee0-9134938f9629SPL set ID 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66RxCUI 1862685, 1862688, 1862691, 1862692, 1862695, 1862697, 1862700, 1862701UNII 786Z46389E, HDC1R2M35U
- 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
N400597028073followed by a unit qualifier and the quantityPackage 00597-0280-73. 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)
SYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, 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. SYNJARDY XR SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes m…
Excerpt only. Read the full label for complete information.
About NDC 0597-0280
- What is NDC 0597-0280?
- 0597-0280 is the product NDC for Synjardy XR, Empagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 tablet, extended release, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Synjardy XR (Empagliflozin, metformin hydrochloride).
- What is the active ingredient?
- Empagliflozin, Metformin hydrochloride.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Synjardy XR?
- 3 other product NDCs are listed under this name. See all Synjardy XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Synjardy XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0290 | 00597-0290-5900597-0290-74 |
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 25 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0295 | 00597-0295-6100597-0295-7800597-0295-88 |
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0300 | 00597-0300-2000597-0300-4500597-0300-93 |
Other NDCs under NDA 208658
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 |
|---|---|---|---|---|
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0290 |
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 25 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0295 |
| Synjardy XRempagliflozin, metformin hydrochloride | Empagliflozin 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0300 |