Azithromycin Dihydrate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Azithromycin Dihydrate.
| Product ID | 53002-2221_0eeb437e-d05a-489d-9b82-6fd264b53eee |
| NDC | 53002-2221 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Azithromycin Dihydrate |
| Generic Name | Azithromycin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-07-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065509 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | AZITHROMYCIN DIHYDRATE |
| Active Ingredient Strength | 500 mg/1 |
| Pharm Classes | Macrolide Antimicrobial [EPC],Macrolides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065509 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA065509 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA065509 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
| SPL SET ID: | 7e228ad6-2c24-4994-a0d0-040f59eaa4d2 |
| 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 |