Prescription drug · NDA
Januvia (Sitagliptin) NDC 0006-0112
Sitagliptin phosphate 50 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-0112-28 | 0000601122800006011228 | 100 BLISTER PACK in 1 CARTON (0006-0112-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)Marketed from Oct 16, 2006 | |
| 0006-0112-31 | 0000601123100006011231 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)Marketed from Oct 16, 2006 | |
| 0006-0112-54 | 0000601125400006011254 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-0112-54)Marketed from Oct 16, 2006 |
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)
- Januvia
- Generic name (nonproprietary)
- sitagliptin
- Active ingredients
- Sitagliptin phosphate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021995
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-0112_71d449de-955b-4711-9a44-1e1f66e2e9ebSPL ID 71d449de-955b-4711-9a44-1e1f66e2e9ebSPL set ID f85a48d0-0407-4c50-b0fa-7673a160bf01RxCUI 665036, 665040, 665044, 2709603, 2709608, 2709612UNII TS63EW8X6FUPC 0300060112317, 0300060221316, 0300060277313
- Pharmacologic class
- 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
N400006011228followed by a unit qualifier and the quantityPackage 00006-0112-28. 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 .
Indications (excerpt from the label)
JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is 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. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increa…
Excerpt only. Read the full label for complete information.
About NDC 0006-0112
- What is NDC 0006-0112?
- 0006-0112 is the product NDC for Januvia (sitagliptin), Sitagliptin phosphate 50 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Januvia (Sitagliptin).
- What is the active ingredient?
- Sitagliptin phosphate.
- 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 Januvia?
- 10 other product NDCs are listed under this name. See all Januvia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Januvia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0221 | 00006-0221-2800006-0221-3100006-0221-54 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0277 | 00006-0277-0200006-0277-1400006-0277-28+4 more |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1036 | 50090-1036-0050090-1036-02 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3472 | 50090-3472-0050090-3472-01 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3527 | 50090-3527-0050090-3527-01 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4084 | 50090-4084-00 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4086 | 50090-4086-00 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4087 | 50090-4087-00 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5040 | 55154-5040-08 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5042 | 55154-5042-08 |
Other NDCs under NDA 021995
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 |
|---|---|---|---|---|
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0221 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0277 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1036 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3472 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3527 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4084 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4086 |
| Januviasitagliptin | Sitagliptin phosphate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4087 |
| Januviasitagliptin | Sitagliptin phosphate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5040 |
| Januviasitagliptin | Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5042 |