Azithromycin Dihydrate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Azithromycin Dihydrate.
| Product ID | 70518-0734_592b8f2b-9951-95b6-e053-2991aa0a4a65 |
| NDC | 70518-0734 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azithromycin Dihydrate |
| Generic Name | Azithromycin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-09-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065507 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | AZITHROMYCIN DIHYDRATE |
| Active Ingredient Strength | 250 mg/1 |
| Pharm Classes | Macrolide Antimicrobial [EPC],Macrolides [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2017-09-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065507 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-14 |
| Marketing End Date | 2020-05-04 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-05-12 |
| Ingredient | Strength |
|---|---|
| AZITHROMYCIN DIHYDRATE | 250 mg/1 |
| SPL SET ID: | 96edc050-85bc-4ea7-9acc-df19f993b80d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68788-9521 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 68788-9529 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 70518-0734 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 70882-107 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 70882-118 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 0904-6405 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 45865-641 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50090-1655 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50090-2334 | azithromycin dihydrate | azithromycin dihydrate |
| 50268-104 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50436-2852 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 53002-2221 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 55154-4333 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 61919-362 | AZITHROMYCIN DIHYDRATE | AZITHROMYCIN DIHYDRATE |
| 63187-284 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 51224-122 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 51224-022 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 51224-222 | Azithromycin dihydrate | Azithromycin dihydrate |
| 50090-4527 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50090-4528 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50090-4601 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50090-4700 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 0527-2750 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 71205-430 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 72789-063 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 72789-081 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 55700-859 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 72189-090 | AZITHROMYCIN DIHYDRATE | AZITHROMYCIN DIHYDRATE |
| 71205-491 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50268-076 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 53002-7221 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 50268-074 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 76420-046 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 53002-0474 | Azithromycin Dihydrate | Azithromycin Dihydrate |
| 0069-0400 | Zithromax | azithromycin dihydrate |
| 0069-3051 | ZITHROMAX | AZITHROMYCIN DIHYDRATE |
| 0069-3060 | Zithromax | azithromycin dihydrate |
| 0069-3070 | Zithromax | azithromycin dihydrate |
| 0069-3080 | ZITHROMAX | AZITHROMYCIN DIHYDRATE |
| 0069-3110 | Zithromax | azithromycin dihydrate |