Budesonide (enteric coated) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alvogen, Inc.. The primary component is Budesonide.
| Product ID | 47781-146_e13a50cc-0126-ffb3-9cc4-cd0d8cf1fcc3 |
| NDC | 47781-146 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Budesonide (enteric coated) |
| Generic Name | Budesonide |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-11-23 |
| Marketing End Date | 2019-08-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206724 |
| Labeler Name | Alvogen, Inc. |
| Substance Name | BUDESONIDE |
| Active Ingredient Strength | 3 mg/1 |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Marketing Start Date | 2016-11-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206724 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-11-28 |
| Marketing End Date | 2019-08-31 |
| Marketing Category | ANDA |
| Application Number | ANDA206724 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-11-23 |
| Marketing End Date | 2016-11-24 |
| Marketing Category | ANDA |
| Application Number | ANDA206724 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-11-23 |
| Marketing End Date | 2016-11-24 |
| Marketing Category | ANDA |
| Application Number | ANDA206724 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-11-23 |
| Marketing End Date | 2016-11-24 |
| Ingredient | Strength |
|---|---|
| BUDESONIDE | 3 mg/1 |
| SPL SET ID: | d6f904dd-6ca2-bfe5-4c0b-f5ad5e1e34f3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| 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 |