FDA.reportPublic FDA data

Pimozide

Product NDC
49884-348
11-digit product format
498840348
Labeler code
49884
Product ID
49884-348_2a1e4060-1340-49c7-86f9-9f4206124b3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pimozide
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA204521
Marketing category
ANDA
Marketing start
2015-09-28
Substance
PIMOZIDE
Active strength
2 mg/1
Pharmacologic classes
Typical 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
Pimozide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIMOZIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1HIZ4DL86F
Rxcui198103, 312439

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
32e789eb-3f22-7ca0-483b-80ac3056b881Product name220151005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-348-01Pimozide100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-348-01EA - Each49884-34876301c69-0c18-4fda-a382-70b7320b3b4912015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIMOZIDEACTIVE INGREDIENT1HIZ4DL86FPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1
PIMOZIDEACTIVE MOIETY1HIZ4DL86FPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-348PIMOZIDE TABLET [ENDO USA, INC.]4Current NDC, Legacy NDC, 1 package rows20240926_70b079e2-a1f7-4a93-8685-d60a4d7c1280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312439pimozide 1 MG Oral TabletPSN70b079e2-a1f7-4a93-8685-d60a4d7c12804
198103pimozide 2 MG Oral TabletPSN70b079e2-a1f7-4a93-8685-d60a4d7c12804
312439pimozide 1 MG Oral TabletSCD70b079e2-a1f7-4a93-8685-d60a4d7c12804
198103pimozide 2 MG Oral TabletSCD70b079e2-a1f7-4a93-8685-d60a4d7c12804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-348-0149884034801100 TABLET in 1 BOTTLE (49884-348-01) 100 tablet2015-09-280000-00-00NoNoCurrent