sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 25 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-521
Product ID 68645-521_4cc29310-2a31-9e2e-e063-6294a90a8e5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2027-12-31
Marketing Start 2016-07-21

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 68645521
Hyphenated Format 68645-521

Supplemental Identifiers

UPC
0368645522548 0368645521541 0368645523545
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
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68645-521-54)
source: ndc

Packages (1)

68645-521-54 30 TABLET in 1 BOTTLE (68645-521-54)

Ingredients (1)

sertraline hydrochloride (25 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": "4cc29310-2a31-9e2e-e063-6294a90a8e5d", "openfda": {"upc": ["0368645522548", "0368645521541", "0368645523545"], "unii": ["UTI8907Y6X"], "spl_set_id": ["bd86b293-dab9-4d37-95eb-2bffca335d16"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68645-521-54)", "package_ndc": "68645-521-54", "marketing_start_date": "20160721"}], "brand_name": "Sertraline Hydrochloride", "product_id": "68645-521_4cc29310-2a31-9e2e-e063-6294a90a8e5d", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68645-521", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA077397", "marketing_category": "ANDA", "marketing_start_date": "20160721", "listing_expiration_date": "20271231"}