quetiapine

Generic: quetiapine

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

Drug Facts

Product Profile

Brand Name quetiapine
Generic Name quetiapine
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

quetiapine fumarate 150 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-613
Product ID 68180-613_851955c8-57fc-490c-b7a8-15a6c87ff06e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204203
Listing Expiration 2026-12-31
Marketing Start 2017-08-22

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180613
Hyphenated Format 68180-613

Supplemental Identifiers

RxCUI
721791 721794 721796 853201 895670
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 ANDA204203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-613-07)
source: ndc

Packages (1)

68180-613-07 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-613-07)

Ingredients (1)

quetiapine fumarate (150 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": "851955c8-57fc-490c-b7a8-15a6c87ff06e", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["721791", "721794", "721796", "853201", "895670"], "spl_set_id": ["7803a290-91c0-4e7f-90b5-d2ff33a46cee"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-613-07)", "package_ndc": "68180-613-07", "marketing_start_date": "20170822"}], "brand_name": "Quetiapine", "product_id": "68180-613_851955c8-57fc-490c-b7a8-15a6c87ff06e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68180-613", "generic_name": "Quetiapine", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "150 mg/1"}], "application_number": "ANDA204203", "marketing_category": "ANDA", "marketing_start_date": "20170822", "listing_expiration_date": "20261231"}