sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sertraline hydrochloride 100 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-147
Product ID 31722-147_174443f7-0f33-47d5-89cd-fce503ec8f36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214790
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

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 31722147
Hyphenated Format 31722-147

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0331722145909 0331722147057 0331722146050 0331722145053 0331722146906 0331722147903 0331722147309 0331722145305 0331722146302
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 ANDA214790 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (31722-147-05)
  • 30 TABLET in 1 BOTTLE (31722-147-30)
  • 90 TABLET in 1 BOTTLE (31722-147-90)
source: ndc

Packages (3)

31722-147-05 500 TABLET in 1 BOTTLE (31722-147-05) 31722-147-30 30 TABLET in 1 BOTTLE (31722-147-30) 31722-147-90 90 TABLET in 1 BOTTLE (31722-147-90)

Ingredients (1)

sertraline hydrochloride (100 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": "174443f7-0f33-47d5-89cd-fce503ec8f36", "openfda": {"upc": ["0331722145909", "0331722147057", "0331722146050", "0331722145053", "0331722146906", "0331722147903", "0331722147309", "0331722145305", "0331722146302"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["de1f85ac-df1b-4b7b-8e18-48ebdc8b9279"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-147-05)", "package_ndc": "31722-147-05", "marketing_start_date": "20210503"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (31722-147-30)", "package_ndc": "31722-147-30", "marketing_start_date": "20210503"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (31722-147-90)", "package_ndc": "31722-147-90", "marketing_start_date": "20210503"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "31722-147_174443f7-0f33-47d5-89cd-fce503ec8f36", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "31722-147", "generic_name": "sertraline hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214790", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}