Budesonide is a Respiratory (inhalation) Suspension in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Budesonide.
| Product ID | 0781-7516_12e4cbdd-c6a9-4681-83b5-d40c9be009ef |
| NDC | 0781-7516 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Budesonide |
| Generic Name | Budesonide |
| Dosage Form | Suspension |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2015-07-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201966 |
| Labeler Name | Sandoz Inc |
| Substance Name | BUDESONIDE |
| Active Ingredient Strength | 1 mg/2mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2015-07-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-06 |
| Marketing Category | ANDA |
| Application Number | ANDA201966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-07-24 |
| Marketing Category | ANDA |
| Application Number | ANDA201966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-07-24 |
| Ingredient | Strength |
|---|---|
| BUDESONIDE | .5 mg/2mL |
| SPL SET ID: | 4830c0dd-6964-4108-89bc-3af039612b95 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-6815 | Budesonide | Budesonide |
| 0093-6816 | Budesonide | Budesonide |
| 0093-6817 | Budesonide | Budesonide |
| 0093-7445 | Budesonide | Budesonide |
| 68151-4374 | Budesonide | Budesonide |
| 68258-8922 | Budesonide | Budesonide |
| 68382-720 | budesonide | budesonide |
| 0487-9601 | Budesonide | Budesonide |
| 0487-9701 | Budesonide | Budesonide |
| 68788-0012 | Budesonide | Budesonide |
| 68682-309 | budesonide | budesonide |
| 68788-6873 | Budesonide | Budesonide |
| 68788-0013 | Budesonide | Budesonide |
| 68788-6796 | Budesonide | Budesonide |
| 68788-7020 | Budesonide | Budesonide |
| 0536-1112 | Budesonide | Budesonide |
| 69842-001 | Budesonide | Budesonide |
| 0574-9855 | budesonide | budesonide |
| 0591-2510 | Budesonide | Budesonide |
| 70771-1075 | budesonide | budesonide |
| 0781-7517 | Budesonide | Budesonide |
| 0781-7515 | Budesonide | Budesonide |
| 0781-7516 | Budesonide | Budesonide |
| 11822-6000 | Budesonide | Budesonide |
| 16714-829 | budesonide | budesonide |
| 21130-710 | Budesonide | Budesonide |
| 36800-113 | Budesonide | Budesonide |
| 46122-389 | Budesonide | Budesonide |
| 49035-703 | Budesonide | Budesonide |
| 51079-020 | Budesonide | Budesonide |
| 0363-0048 | Budesonide | Budesonide |
| 60505-6194 | Budesonide | Budesonide |
| 60429-264 | Budesonide | Budesonide |
| 60505-0820 | BUDESONIDE | BUDESONIDE |
| 60505-0821 | BUDESONIDE | BUDESONIDE |
| 60505-6129 | Budesonide | Budesonide |
| 60687-421 | Budesonide | Budesonide |
| 64980-255 | Budesonide | Budesonide |
| 0378-7155 | Budesonide | Budesonide |
| 65162-778 | 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 |