Prescription drug · ANDA
Linagliptin and metformin hydrochloride NDC 72205-408
Linagliptin 2.5 mg/1; Metformin hydrochloride 850 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-408-01 | 72205040801 | 60 TABLET, FILM COATED in 1 BOTTLE (72205-408-01)Marketed from Nov 4, 2025 | |
| 72205-408-02 | 72205040802 | 180 TABLET, FILM COATED in 1 BOTTLE (72205-408-02)Marketed from Nov 4, 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)
- Linagliptin and metformin hydrochloride
- Generic name (nonproprietary)
- linagliptin and metformin hydrochloride
- Active ingredients
- Linagliptin — 2.5 mg/1Metformin hydrochloride — 850 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208459
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-408_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fbSPL ID 5cff87ef-97f9-4e3c-9e06-fd257f3cb3fbSPL set ID 5cff87ef-97f9-4e3c-9e06-fd257f3cb3fbRxCUI 1243020, 1243027, 1243034UNII 786Z46389E, 3X29ZEJ4R2UPC 0372205408029, 0372205407015, 0372205409019, 0372205407022, 0372205409026, 0372205408012
- Pharmacologic class
- Biguanide; Dipeptidyl Peptidase 4 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
N472205040801followed by a unit qualifier and the quantityPackage 72205-0408-01. 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)
Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2 )]. Linagliptin and metformin hydrochloride tablets are a combination of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208459
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 |
|---|---|---|---|---|
| Linagliptin and metformin hydrochloride | Linagliptin 2.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-409 |
| Linagliptin and metformin hydrochloride | Linagliptin 2.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-407 |