budesonide
- Product NDC
- 16714-829
- 11-digit product format
- 167140829
- Labeler code
- 16714
- Product ID
- 16714-829_1780fdb2-9492-4cec-840e-923f19561188
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Northstar Rx LLC.
- Application
- ANDA206134
- Marketing category
- ANDA
- Marketing start
- 2018-06-25
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- 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 | 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 |
|---|
| 16714-829-01 | budesonide | 100 in 1 BOTTLE | CAPSULE, COATED PELLETS | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-829 | BUDESONIDE CAPSULE, COATED PELLETS [NORTHSTAR RX LLC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250221_a37866df-df07-4f71-8591-98c2804c4794.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 |
|---|
| 16714-829-01 | 16714082901 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-829-01) | 2018-06-25 | 0000-00-00 | No | No | Current |