Budesonide Inhalation
- Product NDC
- 68788-8429
- 11-digit product format
- 687888429
- Labeler code
- 68788
- Product ID
- 68788-8429_0804e044-4488-4f33-a34a-2a5be982cc7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078404
- Marketing category
- ANDA
- Marketing start
- 2023-04-24
- 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 Inhalation
- 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 |
|---|
| 68788-8429-3 | Budesonide Inhalation | 5 in 1 POUCH | SUSPENSION | 5 | | 4 |
| 68788-8429-3 | Budesonide Inhalation | 6 in 1 CARTON | SUSPENSION | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8429 | BUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250210_1d139a25-9c17-4b3e-8ffd-b2d562cc00ee.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 |
|---|
| 68788-8429-3 | 68788842903 | 6 POUCH in 1 CARTON (68788-8429-3) / 5 VIAL in 1 POUCH / 2 mL in 1 VIAL | 6 pouch | 2023-04-24 | No | No | Historical |