FDA.reportPublic FDA data

Quetiapine fumarate

Product NDC
70518-2901
11-digit product format
705182901
Labeler code
70518
Product ID
70518-2901_4d66c2b1-56c9-286a-e063-6394a90a6fcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201109
Marketing category
ANDA
Marketing start
2020-10-07
Substance
QUETIAPINE FUMARATE
Active strength
50 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616487

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2901-02022-02-09C16284748780-1d6a99b39-489d-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
70518-2901-02022-01-28C16284748780-1d6a99b39-489d-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2901-0Quetiapine fumarate30 in 1 BLISTER PACKTABLET305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNc6c454c4-3eae-48ae-bf17-5dccdb6591415
616487quetiapine 50 MG Oral TabletSCDc6c454c4-3eae-48ae-bf17-5dccdb6591415
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYc6c454c4-3eae-48ae-bf17-5dccdb6591415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2901-07051829010030 TABLET in 1 BLISTER PACK (70518-2901-0) 30 tablet2020-10-070000-00-00NoNoCurrent