Over-the-counter drug · ANDA
Budesonide NDC 0363-0048
Budesonide 32 ug/1 · Spray, Metered · Nasal · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0048-01 | 0036300480100363004801 | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jul 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
- WalgreensNDC labeler code 0363
- 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 0363-0048_aa57e2f5-f2ba-4341-bb6c-5d664756478aSPL ID aa57e2f5-f2ba-4341-bb6c-5d664756478aSPL set ID 9d519bf3-8d9b-5208-13c5-308edc24aca7RxCUI 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
N400363004801followed by a unit qualifier and the quantityPackage 00363-0048-01. 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)
Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose itchy nose sneezing
Excerpt only. Read the full label for complete information.
About NDC 0363-0048
- What is NDC 0363-0048?
- 0363-0048 is the product NDC for Budesonide, Budesonide 32 ug/1 spray, metered, listed with the FDA by Walgreens. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Budesonide.
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Budesonide?
- 41 other product NDCs are listed under this name. See all Budesonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Budesonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-889 | 60687-0889-83 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | REMEDYREPACK INC. | 70518-4613 | 70518-4613-00 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | Rugby Laboratories | 0536-1456 | 00536-1456-84 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-703 | 49035-0703-01 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | CVS Pharmacy | 69842-001 | 69842-0001-01 |
| Budesonide | Budesonide 3 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 53746-778 | 53746-0778-10 |
| Budesonide | Budesonide .25 mg/2mL | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-638 | 64980-0638-03 |
| Budesonide | Budesonide .5 mg/2mL | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-639 | 64980-0639-03 |
| budesonide | Budesonide 3 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7313 | 00904-7313-10 |
| Budesonide | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Aurobindo Pharma Limited | 59651-585 | 59651-0585-30 |
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 | Rugby Laboratories | 0536-1456 |
| 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 | Apotex Corp. | 60505-6129 |
| Budesonide | Budesonide 32 ug/1 | Spray, MeteredNasal | CVS Pharmacy | 69842-001 |