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NDC 45802-0627-86 BUDESONIDE 2 mg/1 Details
BUDESONIDE 2 mg/1
BUDESONIDE is a RECTAL AEROSOL, FOAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is BUDESONIDE.
Product Information
| NDC | 45802-0627 |
|---|---|
| Product ID | 45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8 |
| Associated GPIs | |
| GCN Sequence Number | 062689 |
| GCN Sequence Number Description | budesonide FOAM/APPL 2 MG RECTAL |
| HIC3 | Q3B |
| HIC3 Description | RECTAL/LOWER BOWEL PREP.,GLUCOCORT. (NON-HEMORR) |
| GCN | 98463 |
| 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 | AEROSOL, FOAM |
| Route | RECTAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | BUDESONIDE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215328 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0627-86 (45802062786)
| NDC Package Code | 45802-627-86 |
|---|---|
| Billing NDC | 45802062786 |
| Package | 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01) |
| Marketing Start Date | 2023-04-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |