NDC 59762-6443

SERTRALINE HYDROCHLORIDE

Sertraline Hydrochloride

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

• Product ID: 59762-6443_1ef7897d-60bb-4685-820f-21c78a097642
• NDC: 59762-6443
• Product Type: Human Prescription Drug
• Proprietary Name: SERTRALINE HYDROCHLORIDE
• Generic Name: Sertraline Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-12
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA019839
• Labeler Name: Greenstone LLC
• Substance Name: SERTRALINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59762-6443-1

30 TABLET, FILM COATED in 1 BOTTLE (59762-6443-1)

• Marketing Start Date: 2019-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59762-6443-2 [59762644302]

SERTRALINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA019839
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-12

NDC 59762-6443-1 [59762644301]

SERTRALINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA019839
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-12

NDC 59762-6443-3 [59762644303]

SERTRALINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA019839
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-12

Drug Details

Active Ingredients

Ingredient	Strength
SERTRALINE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: 1a58062b-e635-431a-908d-2651c6a4a21c
• Manufacturer:
  • Greenstone LLC
• UNII:
  • UTI8907Y6X
• RxNorm Concept Unique ID - RxCUI:
  • 312941
  • 312938
  • 312940
  • 861064
• UPC Code:
  • 0359762634719
  • 0359762516015
  • 0359762644312

Pharmacological Class

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

NDC Crossover Matching brand name "SERTRALINE HYDROCHLORIDE" or generic name "Sertraline Hydrochloride"

NDC	Brand Name	Generic Name
0143-9580	Sertraline Hydrochloride	sertraline hydrochloride
0143-9581	Sertraline Hydrochloride	sertraline hydrochloride
0143-9582	Sertraline Hydrochloride	sertraline hydrochloride
68071-1317	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-1318	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-1976	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-3071	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-2162	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-3146	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-3309	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68071-4029	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68071-4370	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-3379	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68071-4658	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-4750	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68071-4494	Sertraline Hydrochloride	Sertraline Hydrochloride
68071-4462	Sertraline Hydrochloride	Sertraline Hydrochloride
68084-181	Sertraline Hydrochloride	Sertraline Hydrochloride
68382-043	Sertraline Hydrochloride	Sertraline Hydrochloride
68382-045	Sertraline Hydrochloride	Sertraline Hydrochloride
68387-119	Sertraline Hydrochloride	Sertraline Hydrochloride
68382-044	Sertraline Hydrochloride	Sertraline Hydrochloride
68645-523	Sertraline Hydrochloride	Sertraline Hydrochloride
68645-522	Sertraline Hydrochloride	Sertraline Hydrochloride
68645-521	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-6919	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-6437	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-6835	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-6429	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-7035	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68788-6923	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-7001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
68788-9693	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-9873	Sertraline Hydrochloride	Sertraline Hydrochloride
68788-9872	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-157	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-833	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-155	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-156	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-835	Sertraline Hydrochloride	Sertraline Hydrochloride
69097-834	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-0094	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-0679	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-1276	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-1748	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-1350	Sertraline Hydrochloride	Sertraline Hydrochloride
70518-1615	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
70934-176	Sertraline Hydrochloride	Sertraline Hydrochloride
70934-169	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE
71205-047	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE