NDC 55700-225

Sertraline

Sertraline

Sertraline is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Sertraline Hydrochloride.

• Product ID: 55700-225_79fa65fa-4c8a-4e4e-90ef-07a9bcf6becf
• NDC: 55700-225
• Product Type: Human Prescription Drug
• Proprietary Name: Sertraline
• Generic Name: Sertraline
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077670
• Labeler Name: Quality Care Products, LLC
• Substance Name: SERTRALINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55700-225-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-225-30)

• Marketing Start Date: 2015-02-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55700-225-30 [55700022530]

Sertraline TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077670
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-27
• Marketing End Date: 2019-10-11

Drug Details

Active Ingredients

Ingredient	Strength
SERTRALINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: 6ed2b9b7-e4af-4e28-a7d5-4ccb514af217
• Manufacturer:
  • Quality Care Products, LLC
• UNII:
  • UTI8907Y6X

Pharmacological Class

• Serotonin Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Sertraline" or generic name "Sertraline"

NDC	Brand Name	Generic Name
0143-9654	Sertraline	sertraline hydrochloride
0143-9655	Sertraline	sertraline hydrochloride
0143-9656	Sertraline	sertraline hydrochloride
0615-6558	Sertraline	Sertraline Hydrochloride
0615-6559	Sertraline	Sertraline Hydrochloride
0615-6560	Sertraline	Sertraline Hydrochloride
0615-7989	Sertraline	Sertraline
0615-7990	Sertraline	Sertraline
0615-7991	Sertraline	Sertraline
0904-6924	Sertraline	Sertraline
0904-6925	Sertraline	Sertraline
0904-6926	Sertraline	Sertraline
33261-346	Sertraline	Sertraline
42708-068	Sertraline	Sertraline
43353-809	SERTRALINE	Sertraline
43353-812	SERTRALINE	Sertraline
43353-817	SERTRALINE	Sertraline
50090-0989	Sertraline	Sertraline
50090-0991	Sertraline	Sertraline
50090-3562	SERTRALINE	Sertraline
50090-5848	Sertraline	Sertraline
50436-3520	Sertraline	Sertraline
50436-6304	SERTRALINE	Sertraline Hydrochloride
51655-352	Sertraline	Sertraline
51655-830	Sertraline	Sertraline
51655-979	Sertraline	Sertraline
53217-380	Sertraline	Sertraline
55154-3569	Sertraline	Sertraline
55154-3570	Sertraline	Sertraline
68071-4400	Sertraline	Sertraline
68180-351	Sertraline	Sertraline
68180-352	Sertraline	Sertraline
68180-353	Sertraline	Sertraline
70518-0153	Sertraline	Sertraline
70518-0240	Sertraline	Sertraline
70518-0201	Sertraline	Sertraline
70518-0378	Sertraline	Sertraline
70518-0938	Sertraline	Sertraline
70518-1040	Sertraline	Sertraline
70518-1290	Sertraline	Sertraline
70518-1461	Sertraline	Sertraline
70518-1617	Sertraline	Sertraline
71335-0404	Sertraline	Sertraline
76282-212	SERTRALINE	SERTRALINE
76282-213	SERTRALINE	SERTRALINE
76282-214	SERTRALINE	SERTRALINE
55154-6627	Sertraline	Sertraline
55700-225	Sertraline	Sertraline
55700-222	Sertraline	Sertraline
57297-352	Sertraline	Sertraline