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NDC 65162-0708-83 Azithromycin Monohydrate 100 mg/5mL Details
Azithromycin Monohydrate 100 mg/5mL
Azithromycin Monohydrate is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is AZITHROMYCIN MONOHYDRATE.
MedlinePlus Drug Summary
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. Azithromycin also is used to treat or prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as azithromycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 65162-0708-83Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Azithromycin
Product Information
| NDC | 65162-0708 |
|---|---|
| Product ID | 65162-708_4500d2b6-2bce-4897-b879-663b4ec70102 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Azithromycin Monohydrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azithromycin Monohydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | AZITHROMYCIN MONOHYDRATE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Macrolide Antimicrobial [EPC], Macrolides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205666 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0708-83 (65162070883)
| NDC Package Code | 65162-708-83 |
|---|---|
| Billing NDC | 65162070883 |
| Package | 1 BOTTLE in 1 CARTON (65162-708-83) / 15 mL in 1 BOTTLE |
| Marketing Start Date | 2018-07-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |