Budesonide
- Product NDC
- 0536-1456
- 11-digit product format
- 005361456
- Labeler code
- 0536
- Product ID
- 0536-1456_5592d8c7-a130-4ec6-8b15-9329daeb91c7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Rugby Laboratories
- Application
- ANDA078949
- Marketing category
- ANDA
- Marketing start
- 2025-12-01
- Substance
- BUDESONIDE
- Active strength
- 32 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Budesonide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | 32 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 1797929 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1456-84 | Budesonide | 120 in 1 BOTTLE, SPRAY | SPRAY, METERED | 120 | | 2 |
| 0536-1456-84 | Budesonide | 1 in 1 CARTON | SPRAY, METERED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0536-1456-84 | 00536145684 | 1 BOTTLE, SPRAY in 1 CARTON (0536-1456-84) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-12-01 | No | No | Current |