quetiapine fumarate

Generic: quetiapine fumarate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 200 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-150
Product ID 29300-150_9054a1a7-c7ea-4630-be0b-2dcbe910ca94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202674
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300150
Hyphenated Format 29300-150

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0329300150162
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 ANDA202674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-16)
source: ndc

Packages (3)

29300-150-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-01) 29300-150-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-10) 29300-150-16 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-16)

Ingredients (1)

quetiapine fumarate (200 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": "9054a1a7-c7ea-4630-be0b-2dcbe910ca94", "openfda": {"upc": ["0329300150162"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["bdc9354b-172e-4bb3-895a-6c7cfef0ef14"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-01)", "package_ndc": "29300-150-01", "marketing_start_date": "20160701"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-10)", "package_ndc": "29300-150-10", "marketing_start_date": "20170523"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-150-16)", "package_ndc": "29300-150-16", "marketing_start_date": "20160701"}], "brand_name": "Quetiapine Fumarate", "product_id": "29300-150_9054a1a7-c7ea-4630-be0b-2dcbe910ca94", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "29300-150", "generic_name": "Quetiapine Fumarate", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "200 mg/1"}], "application_number": "ANDA202674", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}