NDC 55289-409
Zoloft
Sertraline Hydrochloride
Zoloft is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Sertraline Hydr.
| Product ID | 55289-409_7c1f717a-826f-a2a7-e053-2a91aa0a6e8d |
| NDC | 55289-409 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zoloft |
| Generic Name | Sertraline Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 1992-02-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019839 |
| Labeler Name | PD-Rx Pharmaceuticals, In |
| Substance Name | SERTRALINE HYDR |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Serotonin Reupt |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 55289-409-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-409-30)
| Marketing Start Date | 2011-09-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 55289-409-60 [55289040960]
Zoloft TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA019839 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-09-08 |
NDC 55289-409-30 [55289040930]
Zoloft TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA019839 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-09-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
Pharmacological Class
- Serotonin Reuptake Inhibitor [EPC]
- Serotonin Uptake Inhibitors [MoA]
NDC Crossover Matching brand name "Zoloft" or generic name "Sertraline Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0049-0050 | Zoloft | sertraline hydrochloride |
| 0049-4900 | Zoloft | sertraline hydrochloride |
| 0049-4910 | Zoloft | sertraline hydrochloride |
| 0049-4940 | Zoloft | sertraline hydrochloride |
| 0049-4960 | Zoloft | sertraline hydrochloride |
| 70518-1913 | Zoloft | Zoloft |
| 55289-409 | Zoloft | Zoloft |
| 67544-080 | Zoloft | Zoloft |
| 67544-298 | Zoloft | Zoloft |
| 0143-9654 | Sertraline | sertraline hydrochloride |
| 0143-9655 | Sertraline | sertraline hydrochloride |
| 0143-9656 | Sertraline | sertraline hydrochloride |
| 0143-9580 | Sertraline Hydrochloride | sertraline hydrochloride |
| 0143-9581 | Sertraline Hydrochloride | sertraline hydrochloride |
| 0143-9582 | Sertraline Hydrochloride | sertraline hydrochloride |
Trademark Results [Zoloft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZOLOFT 74054440 1704085 Live/Registered |
PFIZER INC 1990-04-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.