sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-204
Product ID 70010-204_451bb1f2-98b7-deb2-e063-6394a90aac6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078403
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010204
Hyphenated Format 70010-204

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0370010205031 0370010204034 0370010203037
UNII
UTI8907Y6X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA078403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70010-204-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70010-204-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70010-204-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70010-204-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70010-204-10)
  • 3000 TABLET, FILM COATED in 1 BOTTLE (70010-204-53)
  • 8 BLISTER PACK in 1 CARTON (70010-204-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (7)

70010-204-01 100 TABLET, FILM COATED in 1 BOTTLE (70010-204-01) 70010-204-03 30 TABLET, FILM COATED in 1 BOTTLE (70010-204-03) 70010-204-05 500 TABLET, FILM COATED in 1 BOTTLE (70010-204-05) 70010-204-09 90 TABLET, FILM COATED in 1 BOTTLE (70010-204-09) 70010-204-10 1000 TABLET, FILM COATED in 1 BOTTLE (70010-204-10) 70010-204-53 3000 TABLET, FILM COATED in 1 BOTTLE (70010-204-53) 70010-204-63 8 BLISTER PACK in 1 CARTON (70010-204-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

sertraline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Sertraline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451bb1f2-98b7-deb2-e063-6394a90aac6b", "openfda": {"upc": ["0370010205031", "0370010204034", "0370010203037"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["98960cc1-1d44-4d89-b415-7e250cc762cc"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70010-204-01)", "package_ndc": "70010-204-01", "marketing_start_date": "20230515"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70010-204-03)", "package_ndc": "70010-204-03", "marketing_start_date": "20230515"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70010-204-05)", "package_ndc": "70010-204-05", "marketing_start_date": "20230515"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70010-204-09)", "package_ndc": "70010-204-09", "marketing_start_date": "20230515"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70010-204-10)", "package_ndc": "70010-204-10", "marketing_start_date": "20230515"}, {"sample": false, "description": "3000 TABLET, FILM COATED in 1 BOTTLE (70010-204-53)", "package_ndc": "70010-204-53", "marketing_start_date": "20230515"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (70010-204-63)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70010-204-63", "marketing_start_date": "20230515"}], "brand_name": "Sertraline hydrochloride", "product_id": "70010-204_451bb1f2-98b7-deb2-e063-6394a90aac6b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70010-204", "generic_name": "Sertraline hydrochloride", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA078403", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}