NDC 67046-622

Quetiapine

Quetiapine

Quetiapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Contract Pharmacy Services-pa. The primary component is Quetiapine Fumarate.

Product ID67046-622_5a1a6ce6-741e-6941-e053-2a91aa0a83e7
NDC67046-622
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine
Generic NameQuetiapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-26
Marketing CategoryANDA / ANDA
Application NumberANDA202152
Labeler NameContract Pharmacy Services-PA
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67046-622-14

14 TABLET, FILM COATED in 1 BLISTER PACK (67046-622-14)
Marketing Start Date2017-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67046-622-21 [67046062221]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-15 [67046062215]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-60 [67046062260]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-28 [67046062228]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-07 [67046062207]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-20 [67046062220]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-30 [67046062230]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

NDC 67046-622-14 [67046062214]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:5a1a6ce6-741d-6941-e053-2a91aa0a83e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312743
  • 317174
  • 312745
    • UPC Code
  • 0316729147170
  • 0316729148177
  • 0316729149174

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Quetiapine" or generic name "Quetiapine"

    NDCBrand NameGeneric Name
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine
    68071-2038QuetiapineQuetiapine
    68071-4161QuetiapineQuetiapine
    68788-7185QuetiapineQuetiapine
    68788-7184QuetiapineQuetiapine
    68788-7186QuetiapineQuetiapine
    68788-7412QuetiapineQuetiapine
    70518-0229QuetiapineQuetiapine
    70518-0239QuetiapineQuetiapine
    70518-0289QuetiapineQuetiapine
    70518-0345QuetiapineQuetiapine
    70518-0432QuetiapineQuetiapine
    70518-0889QuetiapineQuetiapine
    70518-0808QuetiapineQuetiapine
    70518-0825QuetiapineQuetiapine
    70518-0570QuetiapineQuetiapine
    70518-0752QuetiapineQuetiapine
    70518-1477QuetiapineQuetiapine
    70518-1569QuetiapineQuetiapine
    71205-026QuetiapineQuetiapine
    71335-0432QuetiapineQuetiapine
    0615-7987QuetiapineQuetiapine
    0615-7988QuetiapineQuetiapine
    0615-7986QuetiapineQuetiapine
    0615-8119QuetiapineQuetiapine
    16714-452QuetiapineQuetiapine
    16729-145QuetiapineQuetiapine
    16714-455QuetiapineQuetiapine
    16729-147QuetiapineQuetiapine
    16714-456QuetiapineQuetiapine
    16714-453QuetiapineQuetiapine
    16714-457QuetiapineQuetiapine
    16729-146QuetiapineQuetiapine
    16729-149QuetiapineQuetiapine
    16714-454QuetiapineQuetiapine
    16729-150QuetiapineQuetiapine
    16729-148QuetiapineQuetiapine
    33342-135QUETIAPINEQUETIAPINE
    33342-137QUETIAPINEQUETIAPINE
    33342-134QUETIAPINEQUETIAPINE
    33342-136QUETIAPINEQUETIAPINE
    50090-2831QuetiapineQuetiapine
    50090-2307QuetiapineQuetiapine
    50090-2690QuetiapineQuetiapine
    50090-2830QuetiapineQuetiapine
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