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NDC 65162-0778-10 Budesonide 3 mg/1 Details
Budesonide 3 mg/1
Budesonide is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is BUDESONIDE.
MedlinePlus Drug Summary
Budesonide (Entocort EC) is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn's disease or in the kidney of people with nephropathy.
Related Packages: 65162-0778-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Budesonide
Product Information
| NDC | 65162-0778 |
|---|---|
| Product ID | 65162-778_fba76108-353d-4a7d-8aa2-b05be8f476cb |
| Associated GPIs | 22100012006720 |
| GCN Sequence Number | 025750 |
| GCN Sequence Number Description | budesonide CAPDR - ER 3 MG ORAL |
| HIC3 | P5A |
| HIC3 Description | GLUCOCORTICOIDS |
| GCN | 28680 |
| HICL Sequence Number | 006545 |
| HICL Sequence Number Description | BUDESONIDE |
| Brand/Generic | Generic |
| Proprietary Name | Budesonide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Budesonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | BUDESONIDE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206200 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0778-10 (65162077810)
| NDC Package Code | 65162-778-10 |
|---|---|
| Billing NDC | 65162077810 |
| Package | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10) |
| Marketing Start Date | 2017-09-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.65502 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | BUDESONIDE EC 3 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |