Prescription drug · NDA
Segluromet NDC 0006-5369
ertugliflozin and metformin hydrochloride · Ertugliflozin pidolate 2.5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5369-03 | 00006536903 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-5369-03)Marketed from Dec 19, 2017 | |
| 0006-5369-06 | 00006536906 | 180 TABLET, FILM COATED in 1 BOTTLE (0006-5369-06)Marketed from Dec 19, 2017 | |
| 0006-5369-07 | 00006536907 | 500 TABLET, FILM COATED in 1 BOTTLE (0006-5369-07)Marketed from Dec 19, 2017 |
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)
- Segluromet
- Generic name (nonproprietary)
- ertugliflozin and metformin hydrochloride
- Active ingredients
- Ertugliflozin pidolate — 2.5 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209806
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 0006-5369_208233c5-c2da-4374-bb1d-e71ea3a90028SPL ID 208233c5-c2da-4374-bb1d-e71ea3a90028SPL set ID a6aeb99a-ce49-4125-90ce-642df3f1ebadRxCUI 1992685, 1992691, 1992693, 1992695, 1992698, 1992700, 1992701, 1992703UNII 786Z46389E, MLU731K321UPC 0300065373034, 0300065370033, 0300065374031, 0300065369037
- Pharmacologic class
- Biguanide
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
N400006536903followed by a unit qualifier and the quantityPackage 00006-5369-03. 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)
SEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ].
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 209806
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 |
|---|---|---|---|---|
| Seglurometertugliflozin and metformin hydrochloride | Ertugliflozin pidolate 7.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5374 |
| Seglurometertugliflozin and metformin hydrochloride | Ertugliflozin pidolate 7.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5370 |
| Seglurometertugliflozin and metformin hydrochloride | Ertugliflozin pidolate 2.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5373 |