Budesonide
- Product NDC
- 0904-7166
- 11-digit product format
- 009047166
- Labeler code
- 0904
- Product ID
- 0904-7166_89fd0294-0cf9-4f9e-91d6-6771e390822b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA206200
- Marketing category
- ANDA
- Marketing start
- 2017-09-15
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7166-10 | 00904716610 | 20 BLISTER PACK in 1 CARTON (0904-7166-10) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 20 blister pack | 2017-09-15 | 0000-00-00 | No | No | Current |