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.
| Product ID | 43063-942_80d6f9d5-5e27-379a-e053-2991aa0a5355 |
| NDC | 43063-942 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Clarithromycin |
| Generic Name | Clarithromycin |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-07-23 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208987 |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Substance Name | CLARITHROMYCIN |
| Active Ingredient Strength | 500 mg/1 |
| Pharm Classes | Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-09-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208987 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-09-10 |
| Ingredient | Strength |
|---|---|
| CLARITHROMYCIN | 500 mg/1 |
| SPL SET ID: | 1d328f5d-73c1-4df7-a3df-71d0e0221181 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0036 | Clarithromycin | clarithromycin |
| 0054-0037 | Clarithromycin | clarithromycin |
| 0093-7528 | Clarithromycin | Clarithromycin |
| 0093-7529 | Clarithromycin | Clarithromycin |
| 0527-1930 | Clarithromycin | Clarithromycin |
| 0527-1931 | Clarithromycin | Clarithromycin |
| 0527-1932 | Clarithromycin | Clarithromycin |
| 0591-2805 | clarithromycin | clarithromycin |
| 0781-1961 | Clarithromycin | Clarithromycin |
| 0781-1962 | Clarithromycin | Clarithromycin |
| 0781-6022 | Clarithromycin | Clarithromycin |
| 0781-6023 | Clarithromycin | Clarithromycin |
| 0904-6872 | Clarithromycin | Clarithromycin |
| 10544-522 | Clarithromycin | Clarithromycin |
| 10544-952 | Clarithromycin | clarithromycin |
| 21695-557 | Clarithromycin | Clarithromycin |
| 21695-558 | Clarithromycin | Clarithromycin |
| 27241-064 | Clarithromycin | Clarithromycin |
| 27241-065 | Clarithromycin | Clarithromycin |
| 33261-618 | Clarithromycin | Clarithromycin |
| 33261-631 | Clarithromycin | Clarithromycin |
| 68071-1899 | Clarithromycin | Clarithromycin |
| 68071-3116 | Clarithromycin | Clarithromycin |
| 68084-651 | Clarithromycin | Clarithromycin |
| 68788-6425 | Clarithromycin | Clarithromycin |
| 68788-6967 | Clarithromycin | Clarithromycin |
| 68788-6887 | clarithromycin | clarithromycin |
| 68788-6936 | Clarithromycin | Clarithromycin |
| 68788-7125 | Clarithromycin | Clarithromycin |
| 68788-9087 | Clarithromycin | Clarithromycin |
| 70518-0204 | Clarithromycin | Clarithromycin |
| 70518-1136 | Clarithromycin | Clarithromycin |
| 71335-0017 | Clarithromycin | Clarithromycin |
| 71335-0795 | Clarithromycin | Clarithromycin |
| 75921-962 | Clarithromycin | Clarithromycin |
| 76267-061 | Clarithromycin | Clarithromycin |
| 76267-060 | Clarithromycin | Clarithromycin |
| 42254-188 | Clarithromycin | Clarithromycin |
| 42291-263 | clarithromycin | clarithromycin |
| 43063-530 | Clarithromycin | Clarithromycin |
| 43063-565 | clarithromycin | clarithromycin |
| 43063-752 | Clarithromycin | Clarithromycin |
| 43063-520 | clarithromycin | clarithromycin |
| 43063-823 | Clarithromycin | Clarithromycin |
| 43063-942 | Clarithromycin | Clarithromycin |
| 49884-238 | CLARITHROMYCIN | CLARITHROMYCIN |
| 49999-904 | Clarithromycin | Clarithromycin |
| 50090-0994 | Clarithromycin | Clarithromycin |
| 50090-1410 | clarithromycin | clarithromycin |
| 50090-2515 | Clarithromycin | Clarithromycin |