Prescription drug · NDA
Jardiance (Empagliflozin) NDC 0597-0153
Empagliflozin 25 mg/1 · Tablet, Film coated · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0153-07 | 00597015307 | 1 BOTTLE in 1 CARTON (0597-0153-07) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 1, 2014 · Sample package | |
| 0597-0153-30 | 00597015330 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0153-30)Marketed from Aug 1, 2014 | |
| 0597-0153-37 | 00597015337 | 30 BLISTER PACK in 1 CARTON (0597-0153-37) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 1, 2014 | |
| 0597-0153-90 | 00597015390 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0153-90)Marketed from Aug 1, 2014 |
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)
- Jardiance
- Generic name (nonproprietary)
- empagliflozin
- Active ingredients
- Empagliflozin — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204629
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0153_09daa78d-f417-436c-a29e-029c015ca6d6SPL ID 09daa78d-f417-436c-a29e-029c015ca6d6SPL set ID faf3dd6a-9cd0-39c2-0d2e-232cb3f67565RxCUI 1545658, 1545664, 1545666, 1545668UNII HDC1R2M35U
- Pharmacologic class
- 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
N400597015307followed by a unit qualifier and the quantityPackage 00597-0153-07. 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 .
Indications (excerpt from the label)
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. 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. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular…
Excerpt only. Read the full label for complete information.
About NDC 0597-0153
- What is NDC 0597-0153?
- 0597-0153 is the product NDC for Jardiance (empagliflozin), Empagliflozin 25 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jardiance (Empagliflozin).
- What is the active ingredient?
- Empagliflozin.
- 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 Jardiance?
- 10 other product NDCs are listed under this name. See all Jardiance NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jardiance products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6457 | 50090-6457-00 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-177 | 71610-0177-0971610-0177-1571610-0177-42+3 more |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0411 | 55154-0411-08 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0412 | 55154-0412-08 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-900 | 71610-0900-0971610-0900-97 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2324 | 67296-2324-03 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4384 | 50090-4384-0050090-4384-01 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4492 | 50090-4492-0050090-4492-01 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 00597-0152-0700597-0152-3000597-0152-37+1 more |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6452 | 50090-6452-00 |
Other NDCs under NDA 204629
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 |
|---|---|---|---|---|
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6457 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-177 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0411 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0412 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-900 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2324 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4384 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4492 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6452 |