quetiapine fumarate

Generic: quetiapine fumarate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-902
Product ID 47335-902_c8178883-9da2-4b4f-88ee-182d628a2e41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201190
Listing Expiration 2026-12-31
Marketing Start 2012-03-28

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335902
Hyphenated Format 47335-902

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0347335907889 0347335906882 0347335905885 0347335903881 0347335904888
UNII
2S3PL1B6UJ

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 quetiapine fumarate (source: ndc)
Generic Name quetiapine fumarate (source: ndc)
Application Number ANDA201190 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-902-18)
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-902-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-902-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-902-88)
source: ndc

Packages (4)

47335-902-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-902-18) 47335-902-61 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-902-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK 47335-902-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-902-83) 47335-902-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-902-88)

Ingredients (1)

quetiapine fumarate (25 mg/1)

Linked Drug Pages (1)

Quetiapine fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8178883-9da2-4b4f-88ee-182d628a2e41", "openfda": {"upc": ["0347335907889", "0347335906882", "0347335905885", "0347335903881", "0347335904888"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["ffe52b98-9872-48c1-90fd-8fcd37c3432f"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-902-18)", "package_ndc": "47335-902-18", "marketing_start_date": "20120328"}, {"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-902-61)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "47335-902-61", "marketing_start_date": "20120328"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-902-83)", "package_ndc": "47335-902-83", "marketing_start_date": "20120328"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-902-88)", "package_ndc": "47335-902-88", "marketing_start_date": "20120328"}], "brand_name": "Quetiapine fumarate", "product_id": "47335-902_c8178883-9da2-4b4f-88ee-182d628a2e41", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "47335-902", "generic_name": "Quetiapine fumarate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "25 mg/1"}], "application_number": "ANDA201190", "marketing_category": "ANDA", "marketing_start_date": "20120328", "listing_expiration_date": "20261231"}