NDC 34908-639

Quetiapine Fumarate

Quetiapine Fumarate

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

Product ID34908-639_e131c669-f8b2-4d96-a51f-9d33c31ac3a0
NDC34908-639
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA208947
Labeler NameNovast Laboratories, Ltd.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 34908-639-10

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-10)
Marketing Start Date2017-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 34908-639-30 [34908063930]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 34908-639-60 [34908063960]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 34908-639-90 [34908063990]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 34908-639-10 [34908063910]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Pharmacological Class

  • Atypical Antipsychotic [EPC]

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

NDCBrand NameGeneric Name
0054-0220Quetiapine FumarateQuetiapine Fumarate
0054-0221Quetiapine FumarateQuetiapine Fumarate
0054-0222Quetiapine FumarateQuetiapine Fumarate
0054-0223Quetiapine FumarateQuetiapine Fumarate
0054-0229Quetiapine FumarateQuetiapine Fumarate
0054-0230Quetiapine FumarateQuetiapine Fumarate
67877-242Quetiapine FumarateQuetiapine Fumarate
67877-249Quetiapine FumarateQuetiapine Fumarate
67877-250Quetiapine FumarateQuetiapine Fumarate
67877-246Quetiapine FumarateQuetiapine Fumarate
67877-248Quetiapine FumarateQuetiapine Fumarate
67877-245Quetiapine FumarateQuetiapine Fumarate
67877-247Quetiapine FumarateQuetiapine Fumarate
68001-183Quetiapine fumarateQuetiapine fumarate
68001-182Quetiapine fumarateQuetiapine fumarate
68001-184Quetiapine fumarateQuetiapine fumarate
68001-180Quetiapine fumarateQuetiapine fumarate
68001-185Quetiapine fumarateQuetiapine fumarate
68001-181Quetiapine fumarateQuetiapine fumarate
68071-1892Quetiapine FumarateQuetiapine Fumarate
68180-450Quetiapine fumarateQuetiapine fumarate
68180-447Quetiapine fumarateQuetiapine fumarate
68180-448Quetiapine fumarateQuetiapine fumarate
68151-5225Quetiapine FumarateQuetiapine Fumarate
68180-614Quetiapine fumarateQuetiapine fumarate
68180-613Quetiapine fumarateQuetiapine fumarate
68180-615Quetiapine fumarateQuetiapine fumarate
68180-616Quetiapine fumarateQuetiapine fumarate
68180-445Quetiapine fumarateQuetiapine fumarate
68180-446Quetiapine fumarateQuetiapine fumarate
68180-612Quetiapine fumarateQuetiapine fumarate
68180-449Quetiapine fumarateQuetiapine fumarate
68788-7195Quetiapine fumarateQuetiapine fumarate
68788-9487Quetiapine fumarateQuetiapine fumarate
68788-9490Quetiapine FumarateQuetiapine Fumarate
69189-0495Quetiapine FumarateQuetiapine Fumarate
69189-0580Quetiapine FumarateQuetiapine Fumarate
70518-0753quetiapine fumaratequetiapine fumarate
70518-0767Quetiapine fumarateQuetiapine fumarate
70518-0556Quetiapine fumarateQuetiapine fumarate
70518-0638Quetiapine FumarateQuetiapine Fumarate
70518-0594Quetiapine fumarateQuetiapine fumarate
70518-0645Quetiapine FumarateQuetiapine Fumarate
70518-0974Quetiapine FumarateQuetiapine Fumarate
70518-1018Quetiapine FumarateQuetiapine Fumarate
70518-1029quetiapine fumaratequetiapine fumarate
70518-0975Quetiapine FumarateQuetiapine Fumarate
70518-0989Quetiapine FumarateQuetiapine Fumarate
70518-0723Quetiapine FumarateQuetiapine Fumarate
70518-0988Quetiapine fumarateQuetiapine fumarate
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