sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: alvogen, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler alvogen, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 200 mg/1

Manufacturer
Alvogen, Inc.

Identifiers & Regulatory

Product NDC 47781-962
Product ID 47781-962_6dc518cc-d3cf-5888-2b4e-90d598afac58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA215133
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

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 47781962
Hyphenated Format 47781-962

Supplemental Identifiers

RxCUI
251201 410584
UPC
0347781951306 0347781962302
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 NDA215133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (47781-962-30)
source: ndc

Packages (1)

47781-962-30 30 CAPSULE in 1 BOTTLE (47781-962-30)

Ingredients (1)

sertraline hydrochloride (200 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": "6dc518cc-d3cf-5888-2b4e-90d598afac58", "openfda": {"upc": ["0347781951306", "0347781962302"], "unii": ["UTI8907Y6X"], "rxcui": ["251201", "410584"], "spl_set_id": ["e0e1f35e-114d-bb39-34f1-70208b94ac9e"], "manufacturer_name": ["Alvogen, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (47781-962-30)", "package_ndc": "47781-962-30", "marketing_start_date": "20250922"}], "brand_name": "sertraline hydrochloride", "product_id": "47781-962_6dc518cc-d3cf-5888-2b4e-90d598afac58", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "47781-962", "generic_name": "sertraline hydrochloride", "labeler_name": "Alvogen, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sertraline hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "NDA215133", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}