sertraline hcl

Generic: sertraline hydrochloride

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hcl
Generic Name sertraline hydrochloride
Labeler almatica pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 150 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-664
Product ID 52427-664_fee38eb1-855e-a3c0-c707-8665f61fb400
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215133
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

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 52427664
Hyphenated Format 52427-664

Supplemental Identifiers

RxCUI
251201 410584
UPC
0352427664304 0352427672309
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 hcl (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number NDA215133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (52427-664-30)
source: ndc

Packages (1)

52427-664-30 30 CAPSULE in 1 BOTTLE (52427-664-30)

Ingredients (1)

sertraline hydrochloride (150 mg/1)

Linked Drug Pages (1)

sertraline HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fee38eb1-855e-a3c0-c707-8665f61fb400", "openfda": {"upc": ["0352427664304", "0352427672309"], "unii": ["UTI8907Y6X"], "rxcui": ["251201", "410584"], "spl_set_id": ["8c8bcba9-eaeb-aa44-f9ea-b580de55a439"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (52427-664-30)", "package_ndc": "52427-664-30", "marketing_start_date": "20211101"}], "brand_name": "sertraline HCl", "product_id": "52427-664_fee38eb1-855e-a3c0-c707-8665f61fb400", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "52427-664", "generic_name": "sertraline hydrochloride", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sertraline HCl", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "NDA215133", "marketing_category": "NDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}