NDC 0406-1183

Quetiapine Fumarate Extended-Release

Quetiapine Fumarate

Quetiapine Fumarate Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Quetiapine Fumarate.

Product ID0406-1183_9bca76f4-2922-4b22-a6f6-d65a10dc6a84
NDC0406-1183
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate Extended-Release
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA202939
Labeler NameSpecGx LLC
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0406-1183-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1183-60)
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-1183-60 [00406118360]

Quetiapine Fumarate Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202939
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:b56d057a-f5d9-4919-a0f2-b96a76ff83b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791
    • UPC Code
  • 0304061183604
  • 0304061181600
  • 0304061184601
  • 0304061180603
  • 0304061182607

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Quetiapine Fumarate Extended-Release" or generic name "Quetiapine Fumarate"

    NDCBrand NameGeneric Name
    0406-1180Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    0406-1181Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    0406-1183Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    0406-1182Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    0406-1184Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    27808-187Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    27808-189Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    27808-186Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    27808-188Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    27808-185Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
    0054-0220Quetiapine FumarateQuetiapine Fumarate
    0054-0221Quetiapine FumarateQuetiapine Fumarate
    0054-0222Quetiapine FumarateQuetiapine Fumarate
    0054-0223Quetiapine FumarateQuetiapine Fumarate
    0054-0229Quetiapine FumarateQuetiapine Fumarate
    0054-0230Quetiapine FumarateQuetiapine Fumarate
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