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NDC 65862-0905-03 Ipratropium bromide 0.5 mg/2.5mL Details
Ipratropium bromide 0.5 mg/2.5mL
Ipratropium bromide is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is IPRATROPIUM BROMIDE.
MedlinePlus Drug Summary
Ipratropium oral inhalation is used to prevent wheezing, shortness of breath, coughing, and chest tightness in people with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to the air sacs in the lungs). Ipratropium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.
Related Packages: 65862-0905-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ipratropium Oral Inhalation
Product Information
| NDC | 65862-0905 |
|---|---|
| Product ID | 65862-905_08eada61-404a-b5f8-e063-6294a90a74e7 |
| Associated GPIs | 44100030102020 |
| GCN Sequence Number | 021700 |
| GCN Sequence Number Description | ipratropium bromide SOLUTION 0.2 MG/ML INHALATION |
| HIC3 | B60 |
| HIC3 Description | ANTICHOLINERGICS, ORALLY INHALED SHORT ACTING |
| GCN | 42235 |
| HICL Sequence Number | 000057 |
| HICL Sequence Number Description | IPRATROPIUM BROMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Ipratropium bromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ipratropium bromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/2.5mL |
| Substance Name | IPRATROPIUM BROMIDE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206543 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0905-03 (65862090503)
| NDC Package Code | 65862-905-03 |
|---|---|
| Billing NDC | 65862090503 |
| Package | 30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2016-10-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |