Prescription drug · NDA
Jardiance (Empagliflozin) NDC 71610-177
Empagliflozin 25 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-177-09 | 71610017709 | 9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)Marketed from Oct 24, 2018 | |
| 71610-177-15 | 71610017715 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-177-15)Marketed from Sep 18, 2019 | |
| 71610-177-42 | 71610017742 | 1800 TABLET, FILM COATED in 1 BOTTLE (71610-177-42)Marketed from Dec 9, 2022 | |
| 71610-177-45 | 71610017745 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-177-45)Marketed from Oct 3, 2019 | |
| 71610-177-81 | 71610017781 | 1080 TABLET, FILM COATED in 1 BOTTLE (71610-177-81)Marketed from Apr 22, 2025 | |
| 71610-177-99 | 71610017799 | 5040 TABLET, FILM COATED in 1 BOTTLE (71610-177-99)Marketed from Oct 27, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-177_422a084f-5495-2335-e063-6394a90a8736SPL ID 422a084f-5495-2335-e063-6394a90a8736SPL set ID 8b6261f6-4bdc-462e-8af1-4064664c62f3RxCUI 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
N471610017709followed by a unit qualifier and the quantityPackage 71610-0177-09. 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: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. (…
Excerpt only. Read the full label for complete information.
About NDC 71610-177
- What is NDC 71610-177?
- 71610-177 is the product NDC for Jardiance (empagliflozin), Empagliflozin 25 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 10 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 | 00597-0152-0700597-0152-3000597-0152-37+1 more |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0153 | 00597-0153-0700597-0153-3000597-0153-37+1 more |
| 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 | A-S Medication Solutions | 50090-6452 | 50090-6452-00 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6457 | 50090-6457-00 |
| 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 25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2324 | 67296-2324-03 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-900 | 71610-0900-0971610-0900-97 |
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 10 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0152 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0153 |
| 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 | A-S Medication Solutions | 50090-6452 |
| Jardianceempagliflozin | Empagliflozin 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6457 |
| 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 25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2324 |
| Jardianceempagliflozin | Empagliflozin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-900 |