Budesonide
- Product NDC
- 60687-596
- 11-digit product format
- 606870596
- Labeler code
- 60687
- Product ID
- 60687-596_4c9c2d04-caa9-9327-e063-6394a90ac2c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA206134
- Marketing category
- ANDA
- Marketing start
- 2021-03-09
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 1244214 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-596-32 | Budesonide | 20 in 1 BOX, UNIT-DOSE | CAPSULE, COATED PELLETS | 20 | | 4 |
| 60687-596-33 | Budesonide | 1 in 1 BLISTER PACK | CAPSULE, COATED PELLETS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-596 | BUDESONIDE CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241020_4a8e79df-3946-4e9a-b214-e9fdd824b565.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 |
|---|
| 60687-596-32 | 60687059632 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-596-32) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (60687-596-33) | 20 blister pack | 2021-03-09 | 0000-00-00 | No | No | Current |
| 60687-596-33 | 60687059633 | 1 in 1 BLISTER PACK | | | | | | Historical |