quetiapine

Generic: quetiapine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-702
Product ID 71610-702_1b43ca4a-8d47-4085-b50f-b282980f39e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077745
Listing Expiration 2026-12-31
Marketing Start 2022-05-25

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610702
Hyphenated Format 71610-702

Supplemental Identifiers

RxCUI
317174
UNII
2S3PL1B6UJ

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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA077745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-702-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-702-30)
source: ndc

Packages (2)

71610-702-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-702-15) 71610-702-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-702-30)

Ingredients (1)

quetiapine fumarate (200 mg/1)

Linked Drug Pages (1)

Quetiapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b43ca4a-8d47-4085-b50f-b282980f39e3", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["317174"], "spl_set_id": ["fdece055-aeb5-43d6-b730-54dd74bde304"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-702-15)", "package_ndc": "71610-702-15", "marketing_start_date": "20230418"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-702-30)", "package_ndc": "71610-702-30", "marketing_start_date": "20230418"}], "brand_name": "Quetiapine", "product_id": "71610-702_1b43ca4a-8d47-4085-b50f-b282980f39e3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71610-702", "generic_name": "Quetiapine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA077745", "marketing_category": "ANDA", "marketing_start_date": "20220525", "listing_expiration_date": "20261231"}