Prescription drug · NDA
Jascayd (Nerandomilast) NDC 0597-7313
Nerandomilast 18 mg/1 · Tablet, Film coated · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-7313-21 | 00597731321 | 1 BOTTLE, PLASTIC in 1 CARTON (0597-7313-21) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Oct 7, 2025 |
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)
- Jascayd
- Generic name (nonproprietary)
- nerandomilast
- Active ingredients
- Nerandomilast — 18 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218764
- Marketing start
- Listing expires
- Identifiers
- Product ID 0597-7313_7ec9d75b-ba99-4670-9b69-4bf9089232b7SPL ID 7ec9d75b-ba99-4670-9b69-4bf9089232b7SPL set ID fa1b14c6-957f-d326-5099-911bfe33e391RxCUI 2725528, 2725534, 2725537, 2725539UNII I5DGT51IB8
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
N400597731321followed by a unit qualifier and the quantityPackage 00597-7313-21. 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)
JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.
Excerpt only. Read the full label for complete information.
About NDC 0597-7313
- What is NDC 0597-7313?
- 0597-7313 is the product NDC for Jascayd (nerandomilast), Nerandomilast 18 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jascayd (Nerandomilast).
- What is the active ingredient?
- Nerandomilast.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jascayd?
- 1 other product NDC are listed under this name. See all Jascayd NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jascayd products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jascaydnerandomilast | Nerandomilast 9 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-2465 | 00597-2465-41 |
Other NDCs under NDA 218764
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 |
|---|---|---|---|---|
| Jascaydnerandomilast | Nerandomilast 9 mg/1 | Tablet, Film coatedOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-2465 |