Budesonide
- Product NDC
- 68788-7314
- 11-digit product format
- 687887314
- Labeler code
- 68788
- Product ID
- 68788-7314_6911ba37-3588-4dd9-abdf-31ceb65be658
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- INHALANT
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA205710
- Marketing category
- ANDA
- Marketing start
- 2019-01-02
- Substance
- BUDESONIDE
- Active strength
- .5 mg/2mL
- 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
- Brand name suffix
- Inhalation Suspension
- Listing expiration
- 2026-12-31
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 |
|---|
| 68788-7314-3 | BudesonideInhalation Suspension | 5 in 1 POUCH | INHALANT | 5 | | 7 |
| 68788-7314-3 | BudesonideInhalation Suspension | 6 in 1 CARTON | INHALANT | 6 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7314 | BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [PREFERRED PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250213_dcb35488-23c5-4e7b-ab86-8406cf855748.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 |
|---|
| 68788-7314-3 | 68788731403 | 6 POUCH in 1 CARTON (68788-7314-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 6 pouch | 2019-01-02 | 0000-00-00 | No | No | Current |