quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

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

quetiapine fumarate 400 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-312
Product ID 29300-312_c5ece454-9c87-42df-a9f9-fc9806d7c312
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215478
Listing Expiration 2026-12-31
Marketing Start 2022-08-15

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300312
Hyphenated Format 29300-312

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
UPC
0329300311167 0329300312164 0329300310160 0329300309164
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 ANDA215478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-312-16)
source: ndc

Packages (1)

29300-312-16 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-312-16)

Ingredients (1)

quetiapine fumarate (400 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": "c5ece454-9c87-42df-a9f9-fc9806d7c312", "openfda": {"upc": ["0329300311167", "0329300312164", "0329300310160", "0329300309164"], "unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["61695b42-cf71-43e3-8b5d-788fd439489f"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-312-16)", "package_ndc": "29300-312-16", "marketing_start_date": "20220912"}], "brand_name": "Quetiapine", "product_id": "29300-312_c5ece454-9c87-42df-a9f9-fc9806d7c312", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "29300-312", "generic_name": "Quetiapine", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA215478", "marketing_category": "ANDA", "marketing_start_date": "20220815", "listing_expiration_date": "20261231"}