budesonide
- Product NDC
- 68682-309
- 11-digit product format
- 686820309
- Labeler code
- 68682
- Product ID
- 68682-309_2553124a-3ed4-365d-e063-6294a90a4224
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA203634
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-07-10
- Substance
- BUDESONIDE
- Active strength
- 9 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 | 9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X |
| Rxcui | 1366550 |
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 |
|---|
| 68682-309-30 | budesonide | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-309 | BUDESONIDE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241027_a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1.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 |
|---|
| 68682-309-30 | 68682030930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-309-30) | 2018-07-10 | 0000-00-00 | No | No | Current |