NDC 0049-0050

Zoloft

Sertraline Hydrochloride

Zoloft is a Oral Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Sertraline Hydr.

• Product ID: 0049-0050_0a322518-ce09-4f78-a3a6-06359ff6df00
• NDC: 0049-0050
• Product Type: Human Prescription Drug
• Proprietary Name: Zoloft
• Generic Name: Sertraline Hydrochloride
• Dosage Form: Solution, Concentrate
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-06
• Marketing Category: NDA / NDA
• Application Number: NDA020990
• Labeler Name: Roerig
• Substance Name: SERTRALINE HYDR
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Serotonin Reupt
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0049-0050-01

1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) > 60 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-01-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-0050-01 [00049005001]

Zoloft SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA020990
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-01-06

Drug Details

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