sertraline hcl

Generic: sertraline hydrochloride

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hcl
Generic Name sertraline hydrochloride
Labeler biocon pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 150 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-128
Product ID 70377-128_4998256c-f83d-2dad-e063-6394a90a36f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218342
Listing Expiration 2027-12-31
Marketing Start 2026-01-30

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 70377128
Hyphenated Format 70377-128

Supplemental Identifiers

RxCUI
251201 410584
UPC
0370377129117 0370377128110
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 ANDA218342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (70377-128-11)
source: ndc

Packages (1)

70377-128-11 30 CAPSULE in 1 BOTTLE (70377-128-11)

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": "4998256c-f83d-2dad-e063-6394a90a36f9", "openfda": {"upc": ["0370377129117", "0370377128110"], "unii": ["UTI8907Y6X"], "rxcui": ["251201", "410584"], "spl_set_id": ["623b9672-b41e-4ec9-b2cc-f5bb383c39ba"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (70377-128-11)", "package_ndc": "70377-128-11", "marketing_start_date": "20260130"}], "brand_name": "Sertraline HCl", "product_id": "70377-128_4998256c-f83d-2dad-e063-6394a90a36f9", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70377-128", "generic_name": "Sertraline hydrochloride", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline HCl", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA218342", "marketing_category": "ANDA", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}