sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-033
Product ID 43063-033_41364be7-cf7b-cab0-e063-6294a90a9346
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2026-12-31
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 43063033
Hyphenated Format 43063-033

Supplemental Identifiers

RxCUI
312941
UPC
0343063033906
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
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-033-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-033-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-033-90)
source: ndc

Packages (3)

43063-033-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-033-30) 43063-033-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-033-60) 43063-033-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-033-90)

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": "41364be7-cf7b-cab0-e063-6294a90a9346", "openfda": {"upc": ["0343063033906"], "unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["adfcc867-1b6e-4698-94b6-2b4190c4ba3d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-033-30)", "package_ndc": "43063-033-30", "marketing_start_date": "20170627"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-033-60)", "package_ndc": "43063-033-60", "marketing_start_date": "20170912"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-033-90)", "package_ndc": "43063-033-90", "marketing_start_date": "20170414"}], "brand_name": "Sertraline Hydrochloride", "product_id": "43063-033_41364be7-cf7b-cab0-e063-6294a90a9346", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43063-033", "generic_name": "Sertraline Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20160721", "listing_expiration_date": "20261231"}