Fluoxetine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Fluoxetine Hydrochloride.
| Product ID | 68180-998_03e4a711-41ba-41f1-87da-2bda8e336835 |
| NDC | 68180-998 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluoxetine Hydrochloride |
| Generic Name | Fluoxetine Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-06-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211653 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | FLUOXETINE HYDROCHLORIDE |
| Active Ingredient Strength | 10 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 | 2019-08-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-07 |
| Marketing Category | ANDA |
| Application Number | ANDA211653 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-07 |
| Ingredient | Strength |
|---|---|
| FLUOXETINE HYDROCHLORIDE | 10 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-5410 | Fluoxetine Hydrochloride | fluoxetine hydrochloride |
| 0378-5420 | Fluoxetine Hydrochloride | fluoxetine hydrochloride |
| 0615-1387 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 0615-5501 | Fluoxetine Hydrochloride | Fluoxetine |
| 0615-5502 | Fluoxetine Hydrochloride | Fluoxetine |
| 0781-2822 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 0781-2823 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 0781-2824 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 0832-0402 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 70518-0170 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 70518-0642 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 70518-0769 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 70934-141 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 0832-0403 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 21695-321 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 21695-320 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 43353-637 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 43598-632 | Fluoxetine hydrochloride | Fluoxetine hydrochloride |
| 46708-242 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 46708-243 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 47781-600 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 49884-336 | fluoxetine hydrochloride | fluoxetine hydrochloride |
| 49884-335 | fluoxetine hydrochloride | fluoxetine hydrochloride |
| 51655-100 | fluoxetine hydrochloride | fluoxetine hydrochloride |
| 51655-101 | fluoxetine hydrochloride | fluoxetine hydrochloride |
| 51672-5306 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
| 53808-0986 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 53808-0988 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 53808-0366 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 55111-284 | Fluoxetine hydrochloride | Fluoxetine hydrochloride |
| 60760-282 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 61919-099 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
| 63629-6855 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 67046-211 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 67544-848 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 68180-997 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 68180-998 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 68180-999 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride |
| 16714-114 | Fluoxetine hydrochloride | Fluoxetine hydrochloride |
| 0121-0721 | Fluoxetine | FLUOXETINE HYDROCHLORIDE |
| 0121-4721 | Fluoxetine | FLUOXETINE HYDROCHLORIDE |
| 0615-1357 | fluoxetine | fluoxetine hydrochloride |
| 0615-1384 | Fluoxetine | Fluoxetine Hydrochloride |
| 0615-8183 | Fluoxetine | Fluoxetine Hydrochloride |
| 0002-3004 | Prozac | Fluoxetine hydrochloride |
| 0777-3104 | Prozac | Fluoxetine hydrochloride |
| 0777-3105 | Prozac | Fluoxetine hydrochloride |
| 0777-3107 | Prozac | Fluoxetine hydrochloride |
| 0430-0210 | SARAFEM | fluoxetine hydrochloride |
| 0430-0215 | SARAFEM | fluoxetine hydrochloride |