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NDC 43063-0942-14 Clarithromycin 500 mg/1 Details
Clarithromycin 500 mg/1
Clarithromycin is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is CLARITHROMYCIN.
MedlinePlus Drug Summary
Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat. It also is used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. It is used in combination with other medications to eliminate H. pylori, a bacterium that causes ulcers. Clarithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as clarithromycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 43063-0942-14Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clarithromycin
Product Information
| NDC | 43063-0942 |
|---|---|
| Product ID | 43063-942_00236314-8c81-42be-e063-6294a90a20ad |
| Associated GPIs | 03500010007520 |
| GCN Sequence Number | 030495 |
| GCN Sequence Number Description | clarithromycin TAB ER 24H 500 MG ORAL |
| HIC3 | W1D |
| HIC3 Description | MACROLIDE ANTIBIOTICS |
| GCN | 48850 |
| HICL Sequence Number | 006228 |
| HICL Sequence Number Description | CLARITHROMYCIN |
| Brand/Generic | Generic |
| Proprietary Name | Clarithromycin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clarithromycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | CLARITHROMYCIN |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208987 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0942-14 (43063094214)
| NDC Package Code | 43063-942-14 |
|---|---|
| Billing NDC | 43063094214 |
| Package | 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14) |
| Marketing Start Date | 2019-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |