Prescription drug · NDA
Tarpeyo (Budesonide) NDC 81749-004
Budesonide 4 mg/1 · Capsule, Delayed release · Oral · Calliditas Therapeutics AB
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81749-004-01 | 8174900040181749000401 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)Marketed from Dec 15, 2021 |
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)
- Tarpeyo
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 4 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Calliditas Therapeutics ABNDC labeler code 81749
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215935
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 81749-004_48e9b876-94c8-7c9f-e063-6294a90adcefSPL ID 48e9b876-94c8-7c9f-e063-6294a90adcefSPL set ID 938cada4-d6bf-4252-836f-dd40f9eadb4dRxCUI 2587883, 2587889UNII Q3OKS62Q6X
- Pharmacologic class
- Corticosteroid
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
N481749000401followed by a unit qualifier and the quantityPackage 81749-0004-01. 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 .
Indications (excerpt from the label)
TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. TARPEYO is a corticosteroid indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81749-004
- What is NDC 81749-004?
- 81749-004 is the product NDC for Tarpeyo (budesonide), Budesonide 4 mg/1 capsule, delayed release, listed with the FDA by Calliditas Therapeutics AB. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tarpeyo (Budesonide).
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Calliditas Therapeutics AB, NDC labeler code 81749. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tarpeyo?
- 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.