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NDC 42291-0083-03 Azithromycin 500 mg/1 Details
Azithromycin 500 mg/1
Azithromycin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is AZITHROMYCIN DIHYDRATE.
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: 42291-0083-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azithromycin
Product Information
| NDC | 42291-0083 |
|---|---|
| Product ID | 42291-083_0e8b3994-a062-af6e-e063-6294a90a60ad |
| Associated GPIs | 03400010000334 |
| GCN Sequence Number | 022624 |
| GCN Sequence Number Description | azithromycin TABLET 500 MG ORAL |
| HIC3 | W1D |
| HIC3 Description | MACROLIDE ANTIBIOTICS |
| GCN | 61198 |
| HICL Sequence Number | 006334 |
| HICL Sequence Number Description | AZITHROMYCIN |
| Brand/Generic | Generic |
| Proprietary Name | Azithromycin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azithromycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | AZITHROMYCIN DIHYDRATE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Macrolide Antimicrobial [EPC], Macrolides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210001 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 42291-0083-03 (42291008303)
| NDC Package Code | 42291-083-03 |
|---|---|
| Billing NDC | 42291008303 |
| Package | 3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03) |
| Marketing Start Date | 2022-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |