FDA.reportPublic FDA data

QUETIAPINE

Product NDC
43547-019
11-digit product format
435470019
Labeler code
43547
Product ID
43547-019_058aac79-3e9f-46b2-a2f8-693ffb211aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA208781
Marketing category
ANDA
Marketing start
2022-04-01
Substance
QUETIAPINE
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
QUETIAPINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBGL0JSY5SI
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
43547-019-06QUETIAPINE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
43547-019-50QUETIAPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-019QUETIAPINE TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE U.S., LLC]2Current NDC, Legacy NDC, 2 package rows20240606_b0cce89c-0e84-4f60-8e50-0e26c41c2613.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895670QUEtiapine fumarate 150 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791QUEtiapine fumarate 200 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794QUEtiapine fumarate 300 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
721796QUEtiapine fumarate 400 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201QUEtiapine fumarate 50 MG 24HR Extended Release Oral TabletPSNb0cce89c-0e84-4f60-8e50-0e26c41c26132
89567024 HR quetiapine 150 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179124 HR quetiapine 200 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179424 HR quetiapine 300 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
72179624 HR quetiapine 400 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
85320124 HR quetiapine 50 MG Extended Release Oral TabletSCDb0cce89c-0e84-4f60-8e50-0e26c41c26132
895670quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
895670quetiapine 150 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721791quetiapine 200 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721794quetiapine 300 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
721796quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132
853201quetiapine 50 MG 24 HR Extended Release Oral TabletSYb0cce89c-0e84-4f60-8e50-0e26c41c26132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-019-064354700190660 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-06) 2022-04-010000-00-00NoNoCurrent
43547-019-5043547001950500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-50) 2022-04-010000-00-00NoNoCurrent