FDA.reportPublic FDA data

Quetiapine

Product NDC
71205-402
11-digit product format
712050402
Labeler code
71205
Product ID
71205-402_6258bbaf-4ac0-4621-b95e-e6b032aa0518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077745
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
400 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui616483

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-402-30Quetiapine30 in 1 BOTTLETABLET, FILM COATED301
71205-402-60Quetiapine60 in 1 BOTTLETABLET, FILM COATED601
71205-402-90Quetiapine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-402-30EA - Each71205-4025cbc8b19-14e7-4b10-bf84-dbd49160da3d12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-402QUETIAPINE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20200222_6258bbaf-4ac0-4621-b95e-e6b032aa0518.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616483QUEtiapine fumarate 400 MG Oral TabletPSN6258bbaf-4ac0-4621-b95e-e6b032aa05181
616483quetiapine 400 MG Oral TabletSCD6258bbaf-4ac0-4621-b95e-e6b032aa05181
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY6258bbaf-4ac0-4621-b95e-e6b032aa05181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-402-307120504023030 TABLET, FILM COATED in 1 BOTTLE (71205-402-30) 2020-02-130000-00-00NoNoCurrent
71205-402-607120504026060 TABLET, FILM COATED in 1 BOTTLE (71205-402-60) 2020-02-130000-00-00NoNoCurrent
71205-402-907120504029090 TABLET, FILM COATED in 1 BOTTLE (71205-402-90) 2020-02-130000-00-00NoNoCurrent