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NDC 69097-0840-64 Ipratropium Bromide and Albuterol Sulfate 2.5; .5 mg/3mL; mg/3mL Details
Ipratropium Bromide and Albuterol Sulfate 2.5; .5 mg/3mL; mg/3mL
Ipratropium Bromide and Albuterol Sulfate is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is ALBUTEROL SULFATE; IPRATROPIUM BROMIDE.
MedlinePlus Drug Summary
The combination of albuterol and ipratropium is used to prevent wheezing, difficulty breathing, chest tightness, and coughing 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). Albuterol and ipratropium combination is used by people whose symptoms have not been controlled by a single inhaled medication. Albuterol and ipratropium are in a class of medications called bronchodilators. Albuterol and ipratropium combination works by relaxing and opening the air passages to the lungs to make breathing easier.
Related Packages: 69097-0840-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Albuterol and Ipratropium Oral Inhalation
Product Information
| NDC | 69097-0840 |
|---|---|
| Product ID | 69097-840_14b7dfcc-b3a8-4027-9544-8d52ec2aacf3 |
| Associated GPIs | 44209902012015 |
| GCN Sequence Number | 048018 |
| GCN Sequence Number Description | ipratropium/albuterol sulfate AMPUL-NEB 0.5-3MG/3 INHALATION |
| HIC3 | B62 |
| HIC3 Description | BETA-ADRENERGIC AND ANTICHOLINERGIC COMBO, INHALED |
| GCN | 13456 |
| HICL Sequence Number | 009040 |
| HICL Sequence Number Description | IPRATROPIUM BROMIDE/ALBUTEROL SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Ipratropium Bromide and Albuterol Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ipratropium Bromide and Albuterol Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 2.5; .5 |
| Active Ingredient Units | mg/3mL; mg/3mL |
| Substance Name | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE |
| Labeler Name | Cipla USA Inc. |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202496 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 69097-0840-64 (69097084064)
| NDC Package Code | 69097-840-64 |
|---|---|
| Billing NDC | 69097084064 |
| Package | 2 POUCH in 1 CARTON (69097-840-64) / 30 VIAL in 1 POUCH / 3 mL in 1 VIAL |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.07495 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | IPRATROPIUM-ALBUTEROL 0.5-3(2.5) MG/3 ML |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |