FDA.reportPublic FDA data

Quetiapine

Product NDC
71205-401
11-digit product format
712050401
Labeler code
71205
Product ID
71205-401_fbe8f179-fe43-43a4-b592-a31f2ec6aede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
Substance
QUETIAPINE FUMARATE
Active strength
200 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 FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui317174

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
71205-401-30Quetiapine30 in 1 BOTTLETABLET, FILM COATED302
71205-401-60Quetiapine60 in 1 BOTTLETABLET, FILM COATED602
71205-401-90Quetiapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-401-30EA - Each71205-40116799f81-83a2-405a-9d2b-b6a00920a82712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-401QUETIAPINE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221111_7a090720-fd90-4976-9aa2-41812106eb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317174QUEtiapine fumarate 200 MG Oral TabletPSN7a090720-fd90-4976-9aa2-41812106eb702
317174quetiapine 200 MG Oral TabletSCD7a090720-fd90-4976-9aa2-41812106eb702
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY7a090720-fd90-4976-9aa2-41812106eb702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-401-307120504013030 TABLET, FILM COATED in 1 BOTTLE (71205-401-30) 2020-02-130000-00-00NoNoCurrent
71205-401-607120504016060 TABLET, FILM COATED in 1 BOTTLE (71205-401-60) 2020-02-130000-00-00NoNoCurrent
71205-401-907120504019090 TABLET, FILM COATED in 1 BOTTLE (71205-401-90) 2020-02-130000-00-00NoNoCurrent