Prescription drug · NDA
Glyxambi (Empagliflozin and linagliptin) NDC 0597-0182
Empagliflozin 10 mg/1; Linagliptin 5 mg/1 · Tablet, Film coated · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0182-30 | 0059701823000597018230 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0182-30)Marketed from Jan 30, 2015 | |
| 0597-0182-39 | 0059701823900597018239 | 30 BLISTER PACK in 1 CARTON (0597-0182-39) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 30, 2015 | |
| 0597-0182-90 | 0059701829000597018290 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0182-90)Marketed from Jan 30, 2015 |
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)
- Glyxambi
- Generic name (nonproprietary)
- empagliflozin and linagliptin
- Active ingredients
- Empagliflozin — 10 mg/1Linagliptin — 5 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 206073
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0182_16f275d5-7526-4e7a-8776-665a9a6ae37aSPL ID 16f275d5-7526-4e7a-8776-665a9a6ae37aSPL set ID ddbab689-f76c-488c-9613-4168d41dd730RxCUI 1602109, 1602115, 1602118, 1602120UNII HDC1R2M35U, 3X29ZEJ4R2
- Pharmacologic class
- Dipeptidyl Peptidase 4 Inhibitor; 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
N400597018230followed by a unit qualifier and the quantityPackage 00597-0182-30. 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)
GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (14.2) ] . GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in ad…
Excerpt only. Read the full label for complete information.
About NDC 0597-0182
- What is NDC 0597-0182?
- 0597-0182 is the product NDC for Glyxambi, Empagliflozin 10 mg/1; Linagliptin 5 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glyxambi (Empagliflozin and linagliptin).
- What is the active ingredient?
- Empagliflozin, Linagliptin.
- 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 Glyxambi?
- 1 other product NDC are listed under this name. See all Glyxambi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glyxambi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glyxambiempagliflozin and linagliptin | Empagliflozin 25 mg/1; Linagliptin 5 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164 | 00597-0164-3000597-0164-3900597-0164-90 |
Other NDCs under NDA 206073
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 |
|---|---|---|---|---|
| Glyxambiempagliflozin and linagliptin | Empagliflozin 25 mg/1; Linagliptin 5 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164 |