budesonide
- Product NDC
- 0574-9855
- 11-digit product format
- 005749855
- Labeler code
- 0574
- Product ID
- 0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- NDA021324
- Marketing category
- NDA
- Marketing start
- 2018-06-29
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 1244214 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-9855-10 | budesonide | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 0574-9855-10 | budesonide | 1 in 1 CARTON | CAPSULE | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-9855 | BUDESONIDE CAPSULE [PADAGIS US LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241127_3a18d5a7-04c5-4137-8155-70a8adc0a48b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0574-9855-10 | 00574985510 | 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE | 1 bottle | 2018-06-29 | 0000-00-00 | No | No | Current |