Prescription drug · NDA
Janumet XR (Sitagliptin and metformin hydrochloride) NDC 0006-0078
Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated, Extended release · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-0078-28 | 0000600782800006007828 | 2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)Marketed from Feb 2, 2012 · Sample package | |
| 0006-0078-61 | 0000600786100006007861 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)Marketed from Feb 2, 2012 | |
| 0006-0078-62 | 0000600786200006007862 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62)Marketed from Feb 2, 2012 | |
| 0006-0078-82 | 0000600788200006007882 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82)Marketed from Feb 2, 2012 |
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)
- Janumet XRSuffix: XR
- Generic name (nonproprietary)
- sitagliptin and metformin hydrochloride
- Active ingredients
- Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202270
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-0078_44f3c6c6-160a-4cc8-8961-b4f7200b5ce5SPL ID 44f3c6c6-160a-4cc8-8961-b4f7200b5ce5SPL set ID 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50RxCUI 1243833, 1243843, 1243848, 2709470, 2709477, 2709482UNII 786Z46389E, TS63EW8X6F
- 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
N400006007828followed by a unit qualifier and the quantityPackage 00006-0078-28. 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)
JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), 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 for the treatment of type 1 diabetes. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ) Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR has not been studied in patients with a history of pancreatitis. It…
Excerpt only. Read the full label for complete information.
About NDC 0006-0078
- What is NDC 0006-0078?
- 0006-0078 is the product NDC for Janumet XR, Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, extended release, listed with the FDA by Merck Sharp & Dohme LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Janumet XR (Sitagliptin and metformin hydrochloride).
- What is the active ingredient?
- Sitagliptin phosphate, Metformin hydrochloride.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Janumet XR?
- 3 other product NDCs are listed under this name. See all Janumet XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Janumet XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Merck Sharp & Dohme LLC | 0006-0080 | 00006-0080-2800006-0080-6100006-0080-62+1 more |
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Merck Sharp & Dohme LLC | 0006-0081 | 00006-0081-1400006-0081-3100006-0081-54+1 more |
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5504 | 50090-5504-0050090-5504-01 |
Other NDCs under NDA 202270
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 |
|---|---|---|---|---|
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Merck Sharp & Dohme LLC | 0006-0080 |
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Merck Sharp & Dohme LLC | 0006-0081 |
| Janumet XRsitagliptin and metformin hydrochloride | Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5504 |