sertraline hydrochloride

Generic: sertraline hydrochloride

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

Drug Facts

Product Profile

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

sertraline hydrochloride 100 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-353
Product ID 68180-353_37fc8b27-bf23-4fe6-8d44-5331bde5b466
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Listing Expiration 2027-12-31
Marketing Start 2007-02-06

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 68180353
Hyphenated Format 68180-353

Supplemental Identifiers

RxCUI
312938 312940 312941
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 ANDA077670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68180-353-02)
  • 5000 TABLET, FILM COATED in 1 BOTTLE (68180-353-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68180-353-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68180-353-09)
source: ndc

Packages (4)

68180-353-02 500 TABLET, FILM COATED in 1 BOTTLE (68180-353-02) 68180-353-05 5000 TABLET, FILM COATED in 1 BOTTLE (68180-353-05) 68180-353-06 30 TABLET, FILM COATED in 1 BOTTLE (68180-353-06) 68180-353-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-353-09)

Ingredients (1)

sertraline hydrochloride (100 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": "37fc8b27-bf23-4fe6-8d44-5331bde5b466", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["42120ff8-b353-4632-9ea9-54de9a698724"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68180-353-02)", "package_ndc": "68180-353-02", "marketing_end_date": "20280531", "marketing_start_date": "20070206"}, {"sample": false, "description": "5000 TABLET, FILM COATED in 1 BOTTLE (68180-353-05)", "package_ndc": "68180-353-05", "marketing_end_date": "20270531", "marketing_start_date": "20070206"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68180-353-06)", "package_ndc": "68180-353-06", "marketing_end_date": "20280229", "marketing_start_date": "20070206"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68180-353-09)", "package_ndc": "68180-353-09", "marketing_end_date": "20280430", "marketing_start_date": "20070206"}], "brand_name": "Sertraline Hydrochloride", "product_id": "68180-353_37fc8b27-bf23-4fe6-8d44-5331bde5b466", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-353", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA077670", "marketing_category": "ANDA", "marketing_start_date": "20070206", "listing_expiration_date": "20271231"}