Quetiapine

Product NDC
60760-866
11-digit product format
607600866
Labeler code
60760
Product ID
60760-866_3622ca24-c93a-c2af-e063-6394a90a1a41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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

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
60760-866-30QuetiapineExtended Release30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-866-30EA - Each60760-866f0b7e01c-9f41-4cbe-b21e-2060fb09d68d12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSN3622cbd4-d7cb-57d4-e063-6294a90a5f241
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCD3622cbd4-d7cb-57d4-e063-6294a90a5f241
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSY3622cbd4-d7cb-57d4-e063-6294a90a5f241
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSY3622cbd4-d7cb-57d4-e063-6294a90a5f241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-866-306076008663030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-866-30) 2025-05-19NoNoCurrent