budesonide
- Product NDC
- 70518-4613
- 11-digit product format
- 705184613
- Labeler code
- 70518
- Product ID
- 70518-4613_5252be96-0238-7516-e063-6294a90a2329
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- budesonide
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206134
- Marketing category
- ANDA
- Marketing start
- 2026-04-23
- 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 |
|---|
| 70518-4613-0 | budesonide | 50 in 1 BOX | CAPSULE, COATED PELLETS | 50 | | 2 |
| 70518-4613-1 | budesonide | 1 in 1 POUCH | CAPSULE, COATED PELLETS | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4613-0 | 70518461300 | 50 POUCH in 1 BOX (70518-4613-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4613-1) | 50 pouch | 2026-04-23 | No | No | Current |
| 70518-4613-1 | 70518461301 | 1 in 1 POUCH | | | | | Historical |