Fluoxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluoxetine Hydrochloride.
| Product ID | 0378-0735_e4caca4f-07a8-4686-b5f2-5b14070fe413 |
| NDC | 0378-0735 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluoxetine |
| Generic Name | Fluoxetine |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-12-23 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075755 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | FLUOXETINE HYDROCHLORIDE |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2013-12-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075755 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-03-26 |
| Marketing End Date | 2016-05-27 |
| Marketing Category | ANDA |
| Application Number | ANDA075755 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-12-23 |
| Marketing Category | ANDA |
| Application Number | ANDA075755 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-12-23 |
| Ingredient | Strength |
|---|---|
| FLUOXETINE HYDROCHLORIDE | 20 mg/1 |
| SPL SET ID: | de336c75-566f-4083-a31b-842bad668b6e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0807 | Fluoxetine | Fluoxetine |
| 0093-5262 | Fluoxetine | Fluoxetine |
| 0093-7188 | Fluoxetine | Fluoxetine |
| 0093-7198 | Fluoxetine | Fluoxetine |
| 0121-0721 | Fluoxetine | FLUOXETINE HYDROCHLORIDE |
| 0121-4721 | Fluoxetine | FLUOXETINE HYDROCHLORIDE |
| 0378-0734 | Fluoxetine | fluoxetine |
| 0378-0735 | Fluoxetine | fluoxetine |
| 0615-1357 | fluoxetine | fluoxetine hydrochloride |
| 0615-1384 | Fluoxetine | Fluoxetine Hydrochloride |
| 68001-129 | Fluoxetine | Fluoxetine |
| 68071-3130 | Fluoxetine | Fluoxetine |
| 68071-3133 | Fluoxetine | Fluoxetine |
| 68071-3318 | Fluoxetine | Fluoxetine |
| 68071-3367 | Fluoxetine | Fluoxetine |
| 68071-3110 | FLUOXETINE | FLUOXETINE |
| 68071-3284 | Fluoxetine | Fluoxetine |
| 68071-4033 | Fluoxetine | Fluoxetine |
| 68071-4314 | Fluoxetine | Fluoxetine |
| 68071-4043 | Fluoxetine | Fluoxetine |
| 68071-4606 | Fluoxetine | Fluoxetine |
| 68071-4653 | Fluoxetine | Fluoxetine |
| 68071-4671 | Fluoxetine | Fluoxetine |
| 68071-4542 | Fluoxetine | Fluoxetine |
| 68084-101 | Fluoxetine | Fluoxetine |
| 68084-605 | Fluoxetine | Fluoxetine |
| 68645-130 | Fluoxetine | Fluoxetine |
| 68645-131 | Fluoxetine | Fluoxetine |
| 68788-6790 | FLUOXETINE | FLUOXETINE |
| 68788-9223 | Fluoxetine | Fluoxetine |
| 68788-6794 | FLUOXETINE | FLUOXETINE |
| 68788-7356 | Fluoxetine | Fluoxetine |
| 68788-7409 | Fluoxetine | Fluoxetine |
| 68788-9222 | Fluoxetine | Fluoxetine |
| 70518-0262 | FLUOXETINE | FLUOXETINE |
| 70518-0032 | FLUOXETINE | FLUOXETINE |
| 70518-0369 | Fluoxetine | Fluoxetine |
| 70518-0417 | Fluoxetine | Fluoxetine |
| 70518-0997 | Fluoxetine | Fluoxetine |
| 70518-1174 | Fluoxetine | Fluoxetine |
| 70518-0971 | Fluoxetine | Fluoxetine |
| 70518-1432 | Fluoxetine | Fluoxetine |
| 70518-1321 | Fluoxetine | Fluoxetine |
| 70518-1775 | Fluoxetine | Fluoxetine |
| 70518-1359 | Fluoxetine | Fluoxetine |
| 70518-1619 | Fluoxetine | Fluoxetine |
| 70518-1757 | Fluoxetine | Fluoxetine |
| 70518-1987 | Fluoxetine | Fluoxetine |
| 70934-077 | Fluoxetine | Fluoxetine |
| 71205-178 | Fluoxetine | Fluoxetine |