sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4687
Product ID 55154-4687_6c22dff3-21a7-4052-8633-52ebe145e080
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2026-12-31
Marketing Start 2016-12-05

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 551544687
Hyphenated Format 55154-4687

Supplemental Identifiers

RxCUI
312938 312941
UPC
0055154469203 0055154468701
UNII
UTI8907Y6X

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 ANDA077397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-4687-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-4687-0 10 BLISTER PACK in 1 BAG (55154-4687-0) / 1 TABLET 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": "6c22dff3-21a7-4052-8633-52ebe145e080", "openfda": {"upc": ["0055154469203", "0055154468701"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312941"], "spl_set_id": ["7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-4687-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-4687-0", "marketing_start_date": "20161205"}], "brand_name": "Sertraline Hydrochloride", "product_id": "55154-4687_6c22dff3-21a7-4052-8633-52ebe145e080", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55154-4687", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077397", "marketing_category": "ANDA", "marketing_start_date": "20161205", "listing_expiration_date": "20261231"}