quetiapine fumarate

Generic: quetiapine fumarate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 300 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-768
Product ID 31722-768_6c68f74f-289f-4d3a-a0a7-ad6173b6628c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204316
Listing Expiration 2026-12-31
Marketing Start 2022-06-16

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722768
Hyphenated Format 31722-768

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0331722769013 0331722767019 0331722768603 0331722764018 0331722766012 0331722765015
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 ANDA204316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-768-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-768-05)
  • 100 BLISTER PACK in 1 CARTON (31722-768-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-31)
  • 100 BLISTER PACK in 1 CARTON (31722-768-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-33)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-768-60)
source: ndc

Packages (5)

31722-768-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-768-01) 31722-768-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-768-05) 31722-768-32 100 BLISTER PACK in 1 CARTON (31722-768-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-31) 31722-768-34 100 BLISTER PACK in 1 CARTON (31722-768-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-33) 31722-768-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-768-60)

Ingredients (1)

quetiapine fumarate (300 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": "6c68f74f-289f-4d3a-a0a7-ad6173b6628c", "openfda": {"upc": ["0331722769013", "0331722767019", "0331722768603", "0331722764018", "0331722766012", "0331722765015"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["5c6aeb85-3ac2-4448-b544-9a4c5f562ed3"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-768-01)", "package_ndc": "31722-768-01", "marketing_start_date": "20240423"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-768-05)", "package_ndc": "31722-768-05", "marketing_start_date": "20220616"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (31722-768-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-31)", "package_ndc": "31722-768-32", "marketing_start_date": "20220616"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (31722-768-34)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-33)", "package_ndc": "31722-768-34", "marketing_start_date": "20220616"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-768-60)", "package_ndc": "31722-768-60", "marketing_start_date": "20220616"}], "brand_name": "Quetiapine Fumarate", "product_id": "31722-768_6c68f74f-289f-4d3a-a0a7-ad6173b6628c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "31722-768", "generic_name": "Quetiapine Fumarate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA204316", "marketing_category": "ANDA", "marketing_start_date": "20220616", "listing_expiration_date": "20261231"}