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NDC 63629-9093-01 budesonide 9 mg/1 Details
budesonide 9 mg/1
budesonide is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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) in adults and children 8 years of age and older. 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 (Uceris) is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum). 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 ulcerative colitis. or in the kidney of people with nephropathy.
Related Packages: 63629-9093-01Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Budesonide
Product Information
| NDC | 63629-9093 |
|---|---|
| Product ID | 63629-9093_39ccbea8-f559-4a14-be4c-0a2d22d40800 |
| Associated GPIs | |
| GCN Sequence Number | 070506 |
| GCN Sequence Number Description | budesonide TABDR - ER 9 MG ORAL |
| HIC3 | P5A |
| HIC3 Description | GLUCOCORTICOIDS |
| GCN | 34063 |
| 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 | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 9 |
| Active Ingredient Units | mg/1 |
| Substance Name | BUDESONIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA203634 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-9093-01 (63629909301)
| NDC Package Code | 63629-9093-1 |
|---|---|
| Billing NDC | 63629909301 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9093-1) |
| Marketing Start Date | 2023-02-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |