Budesonide
- Product NDC
- 64980-639
- 11-digit product format
- 649800639
- Labeler code
- 64980
- Product ID
- 64980-639_325091e2-1d97-4321-e063-6394a90ae5f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUDESONIDE
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078202
- Marketing category
- ANDA
- Marketing start
- 2025-03-14
- 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 |
|---|
| 64980-639-03 | Budesonide | 5 in 1 POUCH | INHALANT | 5 | | 2 |
| 64980-639-03 | Budesonide | 30 in 1 CARTON | INHALANT | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-639 | BUDESONIDE INHALANT [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 2 package rows | 20250411_3235e2a4-8e12-2d58-e063-6294a90a4936.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 |
|---|
| 64980-639-03 | 64980063903 | 30 POUCH in 1 CARTON (64980-639-03) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE | 30 pouch | 2025-03-14 | No | No | Current |