quetiapine fumarate

Generic: quetiapine fumarate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quetiapine fumarate
Generic Name quetiapine fumarate
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quetiapine fumarate 50 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-135
Product ID 46708-135_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203390
Listing Expiration 2026-12-31
Marketing Start 2017-02-21

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708135
Hyphenated Format 46708-135

Supplemental Identifiers

RxCUI
312743 312744 312745 317174 616483 616487
UPC
0346708138301
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 ANDA203390 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 CARTON (46708-135-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-135-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-135-31)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-135-91)
source: ndc

Packages (4)

46708-135-10 100 TABLET, FILM COATED in 1 CARTON (46708-135-10) 46708-135-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-135-30) 46708-135-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-135-31) 46708-135-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-135-91)

Ingredients (1)

quetiapine fumarate (50 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": "1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6", "openfda": {"upc": ["0346708138301"], "unii": ["2S3PL1B6UJ"], "rxcui": ["312743", "312744", "312745", "317174", "616483", "616487"], "spl_set_id": ["93ab6237-321e-4a2c-b0ca-3fc9acb31f9a"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (46708-135-10)", "package_ndc": "46708-135-10", "marketing_start_date": "20170221"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-135-30)", "package_ndc": "46708-135-30", "marketing_start_date": "20170221"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-135-31)", "package_ndc": "46708-135-31", "marketing_start_date": "20170221"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-135-91)", "package_ndc": "46708-135-91", "marketing_start_date": "20170221"}], "brand_name": "Quetiapine Fumarate", "product_id": "46708-135_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-135", "generic_name": "quetiapine fumarate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quetiapine Fumarate", "active_ingredients": [{"name": "QUETIAPINE FUMARATE", "strength": "50 mg/1"}], "application_number": "ANDA203390", "marketing_category": "ANDA", "marketing_start_date": "20170221", "listing_expiration_date": "20261231"}