FDA.reportPublic FDA data

Quetiapine

Product NDC
51407-801
11-digit product format
514070801
Labeler code
51407
Product ID
51407-801_44234fc0-9f0d-feef-e063-6294a90a8a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209635
Marketing category
ANDA
Marketing start
2017-11-29
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
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S3PL1B6UJ
Rxcui721791, 721794, 721796, 853201, 895670

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
51407-801-60QuetiapineExtended Release60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-801-60EA - Each51407-80118e70f81-c58a-492d-82cd-a1ec3671fe3412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-801QUETIAPINE EXTENDED RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20241027_04cd529c-198b-5b85-e063-6294a90a4684.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSN04cd529c-198b-5b85-e063-6294a90a46843
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCD04cd529c-198b-5b85-e063-6294a90a46843
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSY04cd529c-198b-5b85-e063-6294a90a46843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-801-605140708016060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-801-60) 2023-09-07NoNoHistorical