Quetiapine

Product NDC
71205-026
11-digit product format
712050026
Labeler code
71205
Product ID
71205-026_7a3de2bf-32a1-465e-ae85-bd7e1ad1b205
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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui312745

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
71205-026-03Quetiapine03 in 1 BOTTLETABLET, FILM COATED035
71205-026-30Quetiapine30 in 1 BOTTLETABLET, FILM COATED305
71205-026-60Quetiapine60 in 1 BOTTLETABLET, FILM COATED605
71205-026-90Quetiapine90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-026QUETIAPINE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20220924_dd6b6088-943e-413b-9886-88dd9c622be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312745QUEtiapine fumarate 300 MG Oral TabletPSNdd6b6088-943e-413b-9886-88dd9c622be45
312745quetiapine 300 MG Oral TabletSCDdd6b6088-943e-413b-9886-88dd9c622be45
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSYdd6b6088-943e-413b-9886-88dd9c622be45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-026-03712050026033 TABLET, FILM COATED in 1 BOTTLE (71205-026-03) 2018-05-010000-00-00NoNoCurrent
71205-026-307120500263030 TABLET, FILM COATED in 1 BOTTLE (71205-026-30) 2018-05-010000-00-00NoNoCurrent
71205-026-607120500266060 TABLET, FILM COATED in 1 BOTTLE (71205-026-60) 2018-05-010000-00-00NoNoCurrent
71205-026-907120500269090 TABLET, FILM COATED in 1 BOTTLE (71205-026-90) 2018-05-010000-00-00NoNoCurrent