Budesonide
- Product NDC
- 62135-823
- 11-digit product format
- 621350823
- Labeler code
- 62135
- Product ID
- 62135-823_10690463-7fb3-af77-e063-6294a90ad2de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- SUSPENSION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Chartwell RX, LLC
- Application
- ANDA078202
- Marketing category
- ANDA
- Marketing start
- 2013-10-01
- 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
- 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 | 349094, 351109 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-823-84 | Budesonide | 6 in 1 CARTON | SUSPENSION | 6 | | 1 |
| 62135-823-84 | Budesonide | 5 in 1 POUCH | SUSPENSION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-823 | BUDESONIDE SUSPENSION [CHARTWELL RX, LLC] | 1 | Current NDC, 2 package rows | 20240203_374013c9-18c9-4419-b9fb-9bc5c765688e.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 |
|---|
| 62135-823-84 | 62135082384 | 6 POUCH in 1 CARTON (62135-823-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 6 pouch | 2024-01-30 | No | No | Historical |