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NDC 00536-1112-40 Budesonide 32 ug/1 Details
Budesonide 32 ug/1
Budesonide is a NASAL SPRAY, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is BUDESONIDE.
MedlinePlus Drug Summary
Budesonide nasal spray is used to relieve sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Budesonide nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Budesonide nasal spray is in a class of drugs called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.
Related Packages: 00536-1112-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Budesonide Nasal Spray
Product Information
| NDC | 00536-1112 |
|---|---|
| Product ID | 0536-1112_005a7a28-1bb7-13cf-bf60-baefc96e0927 |
| Associated GPIs | 42200015001810 |
| GCN Sequence Number | 075590 |
| GCN Sequence Number Description | budesonide SPRAY/PUMP 32 MCG NASAL |
| HIC3 | Q7P |
| HIC3 Description | NASAL ANTI-INFLAMMATORY STEROIDS |
| GCN | 40708 |
| 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 OTC DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 32 |
| Active Ingredient Units | ug/1 |
| Substance Name | BUDESONIDE |
| Labeler Name | Rugby Laboratories |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078949 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00536-1112-40 (00536111240)
| NDC Package Code | 0536-1112-40 |
|---|---|
| Billing NDC | 00536111240 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-40) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2016-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |