PAROXETINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.
| Product ID | 68180-647_1dcb4824-4c74-483e-8508-a1e1531e63c0 |
| NDC | 68180-647 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PAROXETINE |
| Generic Name | Paroxetine |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204134 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| Active Ingredient Strength | 13 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 | 2017-03-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204134 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-06 |
| Marketing Category | ANDA |
| Application Number | ANDA204134 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-06 |
| Marketing Category | ANDA |
| Application Number | ANDA204134 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-06 |
| Marketing Category | ANDA |
| Application Number | ANDA204134 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-03-06 |
| Ingredient | Strength |
|---|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 12.5 mg/1 |
| SPL SET ID: | d315e0da-f829-408b-be5d-2bca2e06913c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-7001 | Paroxetine | paroxetine hydrochloride hemihydrate |
| 0378-7002 | Paroxetine | paroxetine hydrochloride hemihydrate |
| 0378-7003 | Paroxetine | paroxetine hydrochloride hemihydrate |
| 0378-7004 | Paroxetine | paroxetine hydrochloride hemihydrate |
| 0574-0279 | Paroxetine | paroxetine |
| 0615-5576 | Paroxetine | Paroxetine |
| 0615-5577 | Paroxetine | Paroxetine |
| 0615-5578 | Paroxetine | Paroxetine |
| 0615-5579 | Paroxetine | Paroxetine |
| 0615-7985 | Paroxetine | paroxetine hydrochloride hemihydrate |
| 0615-8173 | Paroxetine | Paroxetine |
| 0615-8174 | Paroxetine | Paroxetine |
| 0615-8359 | Paroxetine | Paroxetine |
| 0904-5676 | PAROXETINE | paroxetine hydrochloride |
| 0904-5677 | PAROXETINE | paroxetine hydrochloride |
| 0904-5678 | PAROXETINE | paroxetine hydrochloride |
| 0904-5679 | PAROXETINE | paroxetine hydrochloride |
| 68071-1594 | Paroxetine | Paroxetine |
| 68071-1746 | Paroxetine | Paroxetine |
| 68071-1740 | Paroxetine | Paroxetine |
| 68071-3278 | Paroxetine | Paroxetine |
| 68071-4323 | PAROXETINE | PAROXETINE |
| 68071-4315 | Paroxetine | Paroxetine |
| 68071-4283 | PAROXETINE | PAROXETINE |
| 68071-4316 | Paroxetine | Paroxetine |
| 68084-044 | Paroxetine | Paroxetine |
| 68084-045 | Paroxetine | Paroxetine |
| 68084-047 | Paroxetine | Paroxetine |
| 68084-046 | Paroxetine | Paroxetine |
| 68180-647 | PAROXETINE | PAROXETINE |
| 68180-645 | PAROXETINE | PAROXETINE |
| 68180-646 | PAROXETINE | PAROXETINE |
| 68382-097 | Paroxetine | Paroxetine |
| 68382-001 | Paroxetine | Paroxetine |
| 68382-099 | Paroxetine | Paroxetine |
| 68382-098 | Paroxetine | Paroxetine |
| 68788-0797 | Paroxetine | Paroxetine |
| 68788-7410 | Paroxetine | Paroxetine |
| 68788-9074 | Paroxetine | Paroxetine |
| 68788-9118 | Paroxetine | Paroxetine |
| 68788-6977 | Paroxetine | Paroxetine |
| 68788-6870 | Paroxetine | Paroxetine |
| 68788-9694 | PAROXETINE | PAROXETINE |
| 68788-6985 | Paroxetine | Paroxetine |
| 68788-9719 | Paroxetine | Paroxetine |
| 68788-9718 | Paroxetine | Paroxetine |
| 70518-0003 | Paroxetine | Paroxetine |
| 70518-0320 | Paroxetine | Paroxetine |
| 70518-0550 | Paroxetine | Paroxetine |
| 70518-0958 | Paroxetine | Paroxetine |