Clarithromycin Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Estreno Pharmaceuticals, Llc. The primary component is Clarithromycin.
| Product ID | 72763-100_7a5cadda-1ece-4894-8f05-a0f35c984998 |
| NDC | 72763-100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Clarithromycin Extended-Release |
| Generic Name | Clarithromycin |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203243 |
| Labeler Name | Estreno Pharmaceuticals, LLC |
| 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 | 2019-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203243 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-01 |
| Marketing End Date | 2020-04-21 |
| Ingredient | Strength |
|---|---|
| CLARITHROMYCIN | 500 mg/1 |
| SPL SET ID: | fe9266c7-cfa0-45f6-a9e5-be8683ff6fe2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 72763-100 | Clarithromycin Extended-Release | Clarithromycin Extended-Release |
| 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 |