FDA.reportPublic FDA data

QUETIAPINE FUMARATE

Product NDC
16729-096
11-digit product format
167290096
Labeler code
16729
Product ID
16729-096_4390e24f-daa6-84a2-e063-6294a90a48ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA090681
Marketing category
ANDA
Marketing start
2019-01-01
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUETIAPINE FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 895670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-096-12QUETIAPINE FUMARATE60 in 1 BOTTLETABLET, EXTENDED RELEASE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-096-12EA - Each16729-096cba398f4-dbc2-40bd-9d29-2c201308459112017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-096QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 1 package rows20240118_3ffe0294-3959-2755-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN3ffe0294-3959-2755-e054-00144ff8d46c13
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD3ffe0294-3959-2755-e054-00144ff8d46c13
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY3ffe0294-3959-2755-e054-00144ff8d46c13
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN142a781e-9de5-4701-a94a-3a79686e1c737
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD142a781e-9de5-4701-a94a-3a79686e1c737
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY142a781e-9de5-4701-a94a-3a79686e1c737
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY142a781e-9de5-4701-a94a-3a79686e1c737
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN1e2d5b10-3e07-4690-b06f-13e738a179721
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD1e2d5b10-3e07-4690-b06f-13e738a179721
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY1e2d5b10-3e07-4690-b06f-13e738a179721
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY1e2d5b10-3e07-4690-b06f-13e738a179721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-096-121672900961260 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-096-12) 2019-01-010000-00-00NoNoCurrent