Quetiapine

Product NDC
72789-266
11-digit product format
727890266
Labeler code
72789
Product ID
72789-266_31b9bfe1-9c84-b590-e063-6294a90a482c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
Substance
QUETIAPINE FUMARATE
Active strength
50 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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-266-07Quetiapine7 in 1 BOTTLE, PLASTICTABLET, FILM COATED742

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-266-07EA - Each72789-266e19c039b-3a04-4615-86c8-196dacc4f62e12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-266QUETIAPINE FUMARATE TABLET [PD-RX PHARMACEUTICALS, INC.]41Current NDC, Legacy NDC, 1 package rows20240217_da3c9642-9f8d-422b-8e12-2036d68f78ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNda3c9642-9f8d-422b-8e12-2036d68f78ca42
616487quetiapine 50 MG Oral TabletSCDda3c9642-9f8d-422b-8e12-2036d68f78ca42
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYda3c9642-9f8d-422b-8e12-2036d68f78ca42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-266-07727890266077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-266-07) 2022-08-160000-00-00NoNoCurrent