FDA.reportPublic FDA data

Quetiapine Fumarate

Product NDC
71205-788
11-digit product format
712050788
Labeler code
71205
Product ID
71205-788_c1f2ccba-62f3-44e7-b06f-dea61eac9e93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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 Fumarate
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
71205-788-30Quetiapine Fumarate30 in 1 BOTTLETABLET301
71205-788-60Quetiapine Fumarate60 in 1 BOTTLETABLET601
71205-788-90Quetiapine Fumarate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-788-30EA - Each71205-788bd6b6c5f-6bc6-4d0f-81a5-80c6af89bf7b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-788QUETIAPINE FUMARATE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20230408_c1f2ccba-62f3-44e7-b06f-dea61eac9e93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616487QUEtiapine fumarate 50 MG Oral TabletPSNc1f2ccba-62f3-44e7-b06f-dea61eac9e931
616487quetiapine 50 MG Oral TabletSCDc1f2ccba-62f3-44e7-b06f-dea61eac9e931
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSYc1f2ccba-62f3-44e7-b06f-dea61eac9e931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-788-307120507883030 TABLET in 1 BOTTLE (71205-788-30) 30 tablet2023-04-06NoNoHistorical
71205-788-607120507886060 TABLET in 1 BOTTLE (71205-788-60) 60 tablet2023-04-06NoNoHistorical
71205-788-907120507889090 TABLET in 1 BOTTLE (71205-788-90) 90 tablet2023-04-06NoNoHistorical