budesonide inhalation
- Product NDC
- 68788-8503
- 11-digit product format
- 687888503
- Labeler code
- 68788
- Product ID
- 68788-8503_3b3a9e87-3f6a-4168-a2bc-04feee0ae479
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide inhalation
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA210897
- Marketing category
- ANDA
- Marketing start
- 2023-08-09
- Substance
- BUDESONIDE
- Active strength
- .5 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 | .5 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 351109 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8503-3 | budesonide inhalation | 5 in 1 POUCH | SUSPENSION | 5 | | 4 |
| 68788-8503-3 | 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 |
|---|
| 68788-8503 | BUDESONIDE INHALATION SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20250213_dd74e446-7c1b-4f02-9c73-ba716572ee77.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 |
|---|
| 68788-8503-3 | 68788850303 | 6 POUCH in 1 CARTON (68788-8503-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 6 pouch | 2023-08-09 | No | No | Current |