Prescription drug · NDA
Dipentum (Olsalazine sodium) NDC 0037-6860
Olsalazine sodium 250 mg/1 · Capsule, Gelatin coated · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0037-6860-10 | 0003768601000037686010 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)Marketed from May 15, 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)
- Dipentum
- Generic name (nonproprietary)
- olsalazine sodium
- Active ingredients
- Olsalazine sodium — 250 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 0037
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019715
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0037-6860_6ef9e69e-bfc6-4136-a675-ac5519c98d30SPL ID 6ef9e69e-bfc6-4136-a675-ac5519c98d30SPL set ID 8512d0c6-db4e-4673-b3b4-28975c18413fRxCUI 905162, 905164UNII Y7JEW0XG7I
- Pharmacologic class
- Aminosalicylate
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
N400037686010followed by a unit qualifier and the quantityPackage 00037-6860-10. 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)
DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. DIPENTUM is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0037-6860
- What is NDC 0037-6860?
- 0037-6860 is the product NDC for Dipentum (olsalazine sodium), Olsalazine sodium 250 mg/1 capsule, gelatin coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dipentum (Olsalazine sodium).
- What is the active ingredient?
- Olsalazine sodium.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dipentum?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.