quetiapine fumarate

Generic: quetiapine fumarate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quetiapine fumarate 400 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2752
Product ID 70518-2752_4a8df981-e0d0-5d60-e063-6394a90acc19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201109
Listing Expiration 2027-12-31
Marketing Start 2020-05-26

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182752
Hyphenated Format 70518-2752

Supplemental Identifiers

RxCUI
616483
UNII
2S3PL1B6UJ

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 ANDA201109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-2752-0)
source: ndc

Packages (1)

70518-2752-0 30 TABLET in 1 BLISTER PACK (70518-2752-0)

Ingredients (1)

quetiapine fumarate (400 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": "4a8df981-e0d0-5d60-e063-6394a90acc19", "openfda": {"unii": ["2S3PL1B6UJ"], "rxcui": ["616483"], "spl_set_id": ["d38f0f4e-dc0f-4c92-a212-c4da3db74801"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-2752-0)", "package_ndc": "70518-2752-0", "marketing_start_date": "20200526"}], "brand_name": "Quetiapine fumarate", "product_id": "70518-2752_4a8df981-e0d0-5d60-e063-6394a90acc19", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-2752", "generic_name": "quetiapine fumarate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "400 mg/1"}], "application_number": "ANDA201109", "marketing_category": "ANDA", "marketing_start_date": "20200526", "listing_expiration_date": "20271231"}