Budesonide
- Product NDC
- 68258-8922
- 11-digit product format
- 682588922
- Labeler code
- 68258
- Product ID
- 68258-8922_478e24f9-c2b6-4b8e-bfff-73f19b671e86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA077519
- Marketing category
- ANDA
- Marketing start
- 2008-11-19
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 1 mg/2mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68258-8922-5 | Budesonide | 2 mL in 1 VIAL, SINGLE-DOSE | SUSPENSION | 2 | | 1 |
| 68258-8922-5 | Budesonide | 5 in 1 POUCH | SUSPENSION | 5 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-8922 | BUDESONIDE SUSPENSION [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20130831_78d25104-15c6-499c-a748-b3407cd9738e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68258-8922-5 | 68258892205 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | Historical |