quetiapine

Generic: quetiapine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 100 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-250
Product ID 67877-250_96978e8e-30c0-4844-a195-a42abd9615b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201504
Listing Expiration 2026-12-31
Marketing Start 2013-03-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877250
Hyphenated Format 67877-250

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 389201 616483 616487
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 (source: ndc)
Generic Name quetiapine (source: ndc)
Application Number ANDA201504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-250-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (67877-250-10)
  • 1 BLISTER PACK in 1 CARTON (67877-250-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (67877-250-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

67877-250-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-250-01) 67877-250-10 1000 TABLET, FILM COATED in 1 BOTTLE (67877-250-10) 67877-250-33 1 BLISTER PACK in 1 CARTON (67877-250-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK 67877-250-38 10 BLISTER PACK in 1 CARTON (67877-250-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

quetiapine fumarate (100 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": "96978e8e-30c0-4844-a195-a42abd9615b4", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "389201", "616483", "616487"], "spl_set_id": ["3112a006-1c61-47f2-84f5-9a7670d09c9b"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-250-01)", "package_ndc": "67877-250-01", "marketing_start_date": "20130301"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (67877-250-10)", "package_ndc": "67877-250-10", "marketing_start_date": "20130301"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-250-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-250-33", "marketing_start_date": "20130301"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-250-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-250-38", "marketing_start_date": "20130301"}], "brand_name": "Quetiapine", "product_id": "67877-250_96978e8e-30c0-4844-a195-a42abd9615b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67877-250", "generic_name": "Quetiapine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "100 mg/1"}], "application_number": "ANDA201504", "marketing_category": "ANDA", "marketing_start_date": "20130301", "listing_expiration_date": "20261231"}