sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sertraline hydrochloride 20 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-601
Product ID 16714-601_333a4c5b-223c-4bba-aea7-49c56ab5adc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078861
Listing Expiration 2026-12-31
Marketing Start 2008-10-31

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 16714601
Hyphenated Format 16714-601

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 ANDA078861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (16714-601-02) / 60 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

16714-601-02 1 BOTTLE, PLASTIC in 1 CARTON (16714-601-02) / 60 mL in 1 BOTTLE, PLASTIC

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": "333a4c5b-223c-4bba-aea7-49c56ab5adc8", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["861064"], "spl_set_id": ["7f144b68-ae90-483c-b030-f6824662a734"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16714-601-02)  / 60 mL in 1 BOTTLE, PLASTIC", "package_ndc": "16714-601-02", "marketing_start_date": "20081031"}], "brand_name": "Sertraline Hydrochloride", "product_id": "16714-601_333a4c5b-223c-4bba-aea7-49c56ab5adc8", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "16714-601", "generic_name": "Sertraline Hydrochloride", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA078861", "marketing_category": "ANDA", "marketing_start_date": "20081031", "listing_expiration_date": "20261231"}