BUDESONIDE (ENTERIC COATED)
- Product NDC
- 51862-582
- 11-digit product format
- 518620582
- Labeler code
- 51862
- Product ID
- 51862-582_b54202a4-25c1-442a-9b62-c3e20a9701fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA206623
- Marketing category
- ANDA
- Marketing start
- 2016-10-25
- Marketing end
- 2021-06-30
- Substance
- BUDESONIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-582-01 | 51862058201 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-582-01) | 2016-10-25 | 2021-06-30 | No | No | Current |