BUDESONIDE (ENTERIC COATED) is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Budesonide.
| Product ID | 51862-580_6f52d255-0a89-4ad9-abb2-5ae54e76ecdd |
| NDC | 51862-580 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BUDESONIDE (ENTERIC COATED) |
| Generic Name | Budesonide |
| Dosage Form | Capsule, Delayed Release Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-10-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206623 |
| Labeler Name | Mayne Pharma Inc. |
| Substance Name | BUDESONIDE |
| Active Ingredient Strength | 3 mg/1 |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206623 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-10-31 |
| Ingredient | Strength |
|---|---|
| BUDESONIDE | 3 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 47781-146 | Budesonide (enteric coated) | Budesonide (enteric coated) |
| 51862-582 | BUDESONIDE (ENTERIC COATED) | BUDESONIDE (ENTERIC COATED) |
| 55700-590 | BUDESONIDE (ENTERIC COATED) | BUDESONIDE (ENTERIC COATED) |
| 51862-580 | BUDESONIDE (ENTERIC COATED) | BUDESONIDE (ENTERIC COATED) |
| 0093-6815 | Budesonide | Budesonide |
| 0093-6816 | Budesonide | Budesonide |
| 0093-6817 | Budesonide | Budesonide |
| 0093-7445 | Budesonide | Budesonide |
| 0115-1687 | Budesonide Inhalation | Budesonide |
| 0115-1689 | Budesonide Inhalation | Budesonide |
| 0186-0916 | PULMICORT | Budesonide |
| 0186-0917 | PULMICORT | Budesonide |
| 0186-1988 | PULMICORT RESPULES | Budesonide |
| 0186-1989 | PULMICORT RESPULES | Budesonide |
| 0186-1990 | PULMICORT RESPULES | Budesonide |