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Sertraline Hydrochloride
Sertraline Hydrochloride - 0378-8121-05 - (sertraline)
Drug Information of Sertraline Hydrochloride
| Product NDC: | 0378-8121 |
| Proprietary Name: | Sertraline Hydrochloride |
| Non Proprietary Name: | sertraline |
| Active Ingredient(s): | 50 mg/1 & nbsp; sertraline |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Sertraline Hydrochloride
| Product NDC: | 0378-8121 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078626 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130218 |
Package Information of Sertraline Hydrochloride
| Package NDC: | 0378-8121-05 |
| Package Description: | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8121-05) |
NDC Information of Sertraline Hydrochloride
| NDC Code | 0378-8121-05 |
| Proprietary Name | Sertraline Hydrochloride |
| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8121-05) |
| Product NDC | 0378-8121 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | sertraline |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20130218 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | SERTRALINE HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
