Prescription drug · NDA
Eohilia (budesonide) NDC 64764-105
Budesonide 2 mg/10mL · Suspension · Oral · TAKEDA PHARMACEUTICALS AMERICA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-105-00 | 64764010500 | 10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01)Marketed from Feb 9, 2024 | |
| 64764-105-60 | 64764010560 | 60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10)Marketed from Feb 9, 2024 |
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)
- Eohilia
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 2 mg/10mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213976
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccdSPL ID 6b8f012a-d7af-4200-a5b8-5a56f6962ccdSPL set ID 56f2023a-69b2-4470-b4ad-af7ec1be527aRxCUI 2675280, 2675286UNII 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
N464764010500followed by a unit qualifier and the quantityPackage 64764-0105-00. 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)
EOHILIA ™ is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1) , Clinical Studies (14) ]. EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). ( 1 ) Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. ( 1 , 2.1 , 14 )
Excerpt only. Read the full label for complete information.