sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 20 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0067
Product ID 59762-0067_a0edcebe-af2d-463c-aad8-fa5fb77f0828
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020990
Listing Expiration 2026-12-31
Marketing Start 2018-05-15

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 597620067
Hyphenated Format 59762-0067

Supplemental Identifiers

RxCUI
861064
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 NDA020990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

59762-0067-1 1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

sertraline hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Sertraline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0edcebe-af2d-463c-aad8-fa5fb77f0828", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["861064"], "spl_set_id": ["1a58062b-e635-431a-908d-2651c6a4a21c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "59762-0067-1", "marketing_start_date": "20180515"}], "brand_name": "Sertraline hydrochloride", "product_id": "59762-0067_a0edcebe-af2d-463c-aad8-fa5fb77f0828", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "59762-0067", "generic_name": "Sertraline hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "NDA020990", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180515", "listing_expiration_date": "20261231"}