sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-834
Product ID 69097-834_a0c9adca-e44e-4454-8eb5-7dc56b0b73b7
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 69097834
Hyphenated Format 69097-834

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0369097833022 0369097835026 0369097834029
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 ANDA077397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-834-02)
  • 90 TABLET in 1 BOTTLE (69097-834-05)
  • 100 TABLET in 1 BOTTLE (69097-834-07)
  • 500 TABLET in 1 BOTTLE (69097-834-12)
source: ndc

Packages (4)

69097-834-02 30 TABLET in 1 BOTTLE (69097-834-02) 69097-834-05 90 TABLET in 1 BOTTLE (69097-834-05) 69097-834-07 100 TABLET in 1 BOTTLE (69097-834-07) 69097-834-12 500 TABLET in 1 BOTTLE (69097-834-12)

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": "a0c9adca-e44e-4454-8eb5-7dc56b0b73b7", "openfda": {"upc": ["0369097833022", "0369097835026", "0369097834029"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["cf71d1b9-5ebb-429f-a07f-a87cd168250f"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-834-02)", "package_ndc": "69097-834-02", "marketing_start_date": "20160721"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-834-05)", "package_ndc": "69097-834-05", "marketing_start_date": "20160721"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-834-07)", "package_ndc": "69097-834-07", "marketing_start_date": "20160721"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-834-12)", "package_ndc": "69097-834-12", "marketing_start_date": "20160721"}], "brand_name": "Sertraline Hydrochloride", "product_id": "69097-834_a0c9adca-e44e-4454-8eb5-7dc56b0b73b7", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69097-834", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Cipla USA 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"}