budesonide
- Product NDC
- 0904-7313
- 11-digit product format
- 009047313
- Labeler code
- 0904
- Product ID
- 0904-7313_cb9e8049-c3d3-466e-bf9c-3c5032030f4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA206134
- Marketing category
- ANDA
- Marketing start
- 2024-09-03
- Substance
- BUDESONIDE
- Active strength
- 3 mg/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 | 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 |
|---|
| 0904-7313-10 | budesonide | 1 in 1 BLISTER PACK | CAPSULE, COATED PELLETS | 1 | | 2 |
| 0904-7313-10 | budesonide | 20 in 1 CARTON | CAPSULE, COATED PELLETS | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7313 | BUDESONIDE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20250313_e7aca8d1-159e-4aac-b92d-3a69a8edceec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7313-10 | 00904731310 | 20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK | 20 blister pack | 2024-09-03 | No | No | Current |