BUDESONIDE (ENTERIC COATED)
- Product NDC
- 51862-580
- 11-digit product format
- 518620580
- Labeler code
- 51862
- Product ID
- 51862-580_d9a1678d-e215-4bed-a484-317d658fbe11
- 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
- 2019-10-31
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-580 | BUDESONIDE (ENTERIC COATED) (BUDESONIDE) CAPSULE, DELAYED RELEASE PELLETS [MAYNE PHARMA INC.] | 2 | Legacy NDC | 20221213_0659420e-e376-4b90-98bf-71af41c18676.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-580-01 | 51862058001 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01) | 2019-10-31 | 0000-00-00 | No | No | Current |