Ofloxacin Otic is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Ofloxacin.
| Product ID | 53002-2604_90f6aff2-4d88-4e2f-bb40-7f4c9f7ccf2a |
| NDC | 53002-2604 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ofloxacin Otic |
| Generic Name | Ofloxacin |
| Dosage Form | Solution |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2004-05-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076527 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | OFLOXACIN |
| Active Ingredient Strength | 3 mg/mL |
| Pharm Classes | Quinolone Antimicrobial [EPC],Quinolones [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076527 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| OFLOXACIN | 3 mg/mL |
| SPL SET ID: | 7592cf3f-7d4b-436f-89f0-a3686570fef8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-1090 | Ofloxacin Otic | Ofloxacin |
| 68071-1588 | Ofloxacin Otic | Ofloxacin Otic |
| 68071-1630 | Ofloxacin Otic | Ofloxacin Otic |
| 68788-9504 | Ofloxacin Otic | Ofloxacin Otic |
| 53002-2604 | Ofloxacin Otic | Ofloxacin Otic |
| 60505-0363 | Ofloxacin Otic | Ofloxacin Otic |
| 63187-184 | Ofloxacin Otic | Ofloxacin Otic |
| 72189-108 | OFLOXACIN OTIC | OFLOXACIN OTIC |
| 11980-779 | OCUFLOX | ofloxacin |
| 0404-7189 | Ofloxacin | Ofloxacin |
| 0517-0760 | Ofloxacin | Ofloxacin |
| 13985-602 | Ofloxacin | Ofloxacin |
| 17478-713 | Ofloxacin | Ofloxacin |
| 21695-439 | Ofloxacin | Ofloxacin |
| 24208-410 | Ofloxacin | Ofloxacin |
| 24208-434 | Ofloxacin | Ofloxacin |
| 33261-737 | Ofloxacin | Ofloxacin |
| 40042-049 | Ofloxacin | Ofloxacin |
| 42254-257 | Ofloxacin | Ofloxacin |
| 50090-0891 | Ofloxacin | Ofloxacin |
| 50090-1346 | Ofloxacin | Ofloxacin |
| 50090-1736 | Ofloxacin | Ofloxacin |
| 50090-5186 | Ofloxacin | ofloxacin |
| 50090-5209 | Ofloxacin | ofloxacin |
| 50090-5210 | Ofloxacin | ofloxacin |
| 50090-5425 | Ofloxacin | Ofloxacin |
| 50090-5670 | Ofloxacin | Ofloxacin Otic |
| 50383-024 | Ofloxacin | Ofloxacin |