Budesonide
- Product NDC
- 60687-889
- 11-digit product format
- 606870889
- Labeler code
- 60687
- Product ID
- 60687-889_52188517-5a8c-b7e4-e063-6394a90af76b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- American Health Packaging
- Application
- ANDA211922
- Marketing category
- ANDA
- Marketing start
- 2026-05-15
- Substance
- BUDESONIDE
- Active strength
- .25 mg/2mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Budesonide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | .25 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 349094 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-889-79 | Budesonide | 1 in 1 POUCH | SUSPENSION | 1 | | 3 |
| 60687-889-79 | Budesonide | 2 mL in 1 AMPULE | SUSPENSION | 2 | | 3 |
| 60687-889-83 | Budesonide | 30 in 1 CARTON | SUSPENSION | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-889-79 | 60687088979 | 1 in 1 POUCH | | | | | Historical |
| 60687-889-83 | 60687088983 | 30 POUCH in 1 CARTON (60687-889-83) / 1 AMPULE in 1 POUCH (60687-889-79) / 2 mL in 1 AMPULE | 30 pouch | 2026-05-15 | No | No | Current |