Over-the-counter drug · ANDA
Budesonide NDC 0536-1456
Budesonide 32 ug/1 · Spray, Metered · Nasal · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1456-84 | 00536145684 | 1 BOTTLE, SPRAY in 1 CARTON (0536-1456-84) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Dec 1, 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)
- Budesonide
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 32 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078949
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0536-1456_5592d8c7-a130-4ec6-8b15-9329daeb91c7SPL ID 5592d8c7-a130-4ec6-8b15-9329daeb91c7SPL set ID b83af99e-1619-48ed-a033-e5207033f77eRxCUI 1797929UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400536145684followed by a unit qualifier and the quantityPackage 00536-1456-84. 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)
Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078949
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 |
|---|---|---|---|---|
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Rugby Laboratories | 0536-1112 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-703 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | CVS Pharmacy | 69842-001 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0048 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-6129 |