Budesonide
- Product NDC
- 55154-4849
- 11-digit product format
- 551544849
- Labeler code
- 55154
- Product ID
- 55154-4849_7f50d9f4-6e77-40cc-8701-63f8aaaa0d98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA077519
- Marketing category
- ANDA
- Marketing start
- 2019-01-11
- 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
- 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 |
|---|
| 55154-4849-5 | Budesonide | 5 in 1 BAG | SUSPENSION | 5 | | 7 |
| 55154-4849-5 | Budesonide | 2 mL in 1 VIAL, SINGLE-DOSE | SUSPENSION | 2 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-4849 | BUDESONIDE SUSPENSION [CARDINAL HEALTH 107, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240430_3e8a6cf4-4bda-4e22-8653-12635adfb316.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-4849-5 | 55154484905 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5) / 2 mL in 1 VIAL, SINGLE-DOSE | 2019-01-11 | 0000-00-00 | No | No | Current |