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NDC 00115-1687-74 Budesonide Inhalation 0.25 mg/2mL Details
Budesonide Inhalation 0.25 mg/2mL
Budesonide Inhalation is a RESPIRATORY (INHALATION) SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is BUDESONIDE.
MedlinePlus Drug Summary
Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.
Related Packages: 00115-1687-74Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Budesonide Oral Inhalation
Product Information
| NDC | 00115-1687 |
|---|---|
| Product ID | 0115-1687_2404cb3e-b023-4709-a32e-3da5d7db731b |
| Associated GPIs | 44400015001830 |
| GCN Sequence Number | 046525 |
| GCN Sequence Number Description | budesonide AMPUL-NEB 0.25MG/2ML INHALATION |
| HIC3 | B6M |
| HIC3 Description | GLUCOCORTICOIDS, ORALLY INHALED |
| GCN | 17957 |
| HICL Sequence Number | 006545 |
| HICL Sequence Number Description | BUDESONIDE |
| Brand/Generic | Generic |
| Proprietary Name | Budesonide Inhalation |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Budesonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/2mL |
| Substance Name | BUDESONIDE |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078404 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00115-1687-74 (00115168774)
| NDC Package Code | 0115-1687-74 |
|---|---|
| Billing NDC | 00115168774 |
| Package | 6 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIAL |
| Marketing Start Date | 2016-08-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.04496 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | BUDESONIDE 0.25 MG/2 ML SUSP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
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