quetiapine fumarate

Generic: quetiapine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-382
Product ID 60687-382_19c30b16-d7bb-ccf7-e063-6394a90a800b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2026-12-31
Marketing Start 2017-10-03

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687382
Hyphenated Format 60687-382

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
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 fumarate (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-382-01) / 1 TABLET in 1 BLISTER PACK (60687-382-11)
source: ndc

Packages (1)

60687-382-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-382-01) / 1 TABLET in 1 BLISTER PACK (60687-382-11)

Ingredients (1)

quetiapine fumarate (400 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": "19c30b16-d7bb-ccf7-e063-6394a90a800b", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["9f927ae2-a0ae-4953-99ba-8de59ee5bfca"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-382-01)  / 1 TABLET in 1 BLISTER PACK (60687-382-11)", "package_ndc": "60687-382-01", "marketing_start_date": "20171003"}], "brand_name": "Quetiapine fumarate", "product_id": "60687-382_19c30b16-d7bb-ccf7-e063-6394a90a800b", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60687-382", "generic_name": "Quetiapine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20171003", "listing_expiration_date": "20261231"}