FDA.reportPublic FDA data

ABILIFY

Product NDC
59148-009
11-digit product format
591480009
Labeler code
59148
Product ID
59148-009_1b189d15-798d-4bed-a93d-a543ed7abd81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA021436
Marketing category
NDA
Marketing start
2002-11-15
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021436-001ABILIFYARIPIPRAZOLE10MGTABLET / ORALABRLD, RS2002-11-15
N021436-002ABILIFYARIPIPRAZOLE15MGTABLET / ORALABRLD2002-11-15
N021436-003ABILIFYARIPIPRAZOLE20MGTABLET / ORALABRLD2002-11-15
N021436-004ABILIFYARIPIPRAZOLE30MGTABLET / ORALABRLD2002-11-15
N021436-005ABILIFYARIPIPRAZOLE5MGTABLET / ORALABRLD2002-11-15
N021436-006ABILIFYARIPIPRAZOLE2MGTABLET / ORALABRLD2002-11-15

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N021436-001AB
N021436-002AB
N021436-003AB
N021436-004AB
N021436-005AB
N021436-006AB

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021436-00191259392026-07-28U-17492015-10-07
N021436-00187593502027-03-02U-15292014-07-22
N021436-00291259392026-07-28U-17492015-10-07
N021436-00287593502027-03-02U-15292014-07-22
N021436-00391259392026-07-28U-17492015-10-07
N021436-00387593502027-03-02U-15292014-07-22
N021436-00491259392026-07-28U-17492015-10-07
N021436-00487593502027-03-02U-15292014-07-22
N021436-00591259392026-07-28U-17492015-10-07
N021436-00587593502027-03-02U-15292014-07-22
N021436-00691259392026-07-28U-17492015-10-07
N021436-00687593502027-03-02U-15292014-07-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (5.3) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.3) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.3 )

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.1 , 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain ( 5.6 ) Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes ( 5.6 ) Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ( 5.6 ) Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation ( 5.7 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.8 ) Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors ( 5.10 ) Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold ( 5.11 ) Potential for Cognitive and Motor Impairment: Use caution when operating machinery ( 5.12 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients ( 5.14 ) 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psycho...

warnings and cautions table

Table 3:Age RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients TreatedIncreases Compared to Placebo<1814 additional cases18 to 245 additional casesDecreases Compared to Placebo25 to 641 fewer case≥656 fewer cases

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia [see Warnings and Precautions (5.15) ] Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were ( 6.1 ): Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy Pediatric patients (6 to 18 years) with Tourette's Disorder: sedation, somnolence, nausea, headach...

adverse reactions table

Table 14: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Adult Patients with Bipolar Mania Treated with ABILIFY MonotherapyPreferred TermPercentage of Patients Reporting ReactionABILIFY (n=917)Placebo (n=753) Akathisia134Sedation83Restlessness63Tremor63Extrapyramidal Disorder52

Additional Listing Data#

Finished product
Yes
Brand name base
ABILIFY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, 602964, 615172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59148-009-132021-08-04C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002
59148-009-352021-08-04C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002
59148-009-952021-08-04C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002
59148-009-132021-07-23C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002
59148-009-352021-07-23C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002
59148-009-952021-07-23C16284748780-1c7ccaba7-1f9b-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-009-13ABILIFY30 in 1 BOTTLE, PLASTICTABLET3073
59148-009-35ABILIFY100 in 1 BLISTER PACKTABLET10073
59148-009-95ABILIFY7 in 1 BLISTER PACKTABLET773

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-009-13EA - Each59148-00980014c8a-7f01-496e-9a91-9b6b1a67e14412012-07-24
59148-009-35EA - Each59148-009ca630bb1-7d1a-42dd-a9aa-b79d772a2adc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
CROSPOVIDONEINACTIVE INGREDIENT68401960MKABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
GLYCERININACTIVE INGREDIENTPDC6A3C0OXABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
LACTIC ACID, DL-INACTIVE INGREDIENT3B8D35Y7S4ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
PHENYLALANINEINACTIVE INGREDIENT47E5O17Y3RABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
SUCROSEINACTIVE INGREDIENTC151H8M554ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507ABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
WATERINACTIVE INGREDIENT059QF0KO0RABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EABILIFY (ARIPIPRAZOLE) TABLET ABILIFY (ARIPIPRAZOLE) SOLUTION ABILIFY DISCMELT (ARIPIPRAZOLE) TABLET, ORALLY DISINTEGRATING ABILIFY (ARIPIPRAZOLE) INJECTION, SOLUTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]56
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-009ABILIFY (ARIPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]73Current NDC, Legacy NDC, 3 package rows20250201_c040bd1d-45b7-49f2-93ea-aed7220b30ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352307ABILIFY 10 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352308ABILIFY 15 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
615172ABILIFY 2 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352309ABILIFY 20 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352310ABILIFY 30 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
404602ABILIFY 5 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349545ARIPiprazole 10 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349490ARIPiprazole 15 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
602964ARIPiprazole 2 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349553ARIPiprazole 20 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349547ARIPiprazole 30 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
402131ARIPiprazole 5 MG Oral TabletPSNc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352307aripiprazole 10 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352308aripiprazole 15 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
615172aripiprazole 2 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352309aripiprazole 20 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352310aripiprazole 30 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
404602aripiprazole 5 MG Oral Tablet [Abilify]SBDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349545aripiprazole 10 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349490aripiprazole 15 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
602964aripiprazole 2 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349553aripiprazole 20 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
349547aripiprazole 30 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
402131aripiprazole 5 MG Oral TabletSCDc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352307Abilify 10 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352308Abilify 15 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
615172Abilify 2 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352309Abilify 20 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352310Abilify 30 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
404602Abilify 5 MG Oral TabletSYc040bd1d-45b7-49f2-93ea-aed7220b30ac73
352308ABILIFY 15 MG Oral TabletPSNf9648990-0627-4c66-aae1-d3eef398b5b43
349490ARIPiprazole 15 MG Oral TabletPSNf9648990-0627-4c66-aae1-d3eef398b5b43
352308aripiprazole 15 MG Oral Tablet [Abilify]SBDf9648990-0627-4c66-aae1-d3eef398b5b43
349490aripiprazole 15 MG Oral TabletSCDf9648990-0627-4c66-aae1-d3eef398b5b43
352308Abilify 15 MG Oral TabletSYf9648990-0627-4c66-aae1-d3eef398b5b43
352308ABILIFY 15 MG Oral TabletPSNd0640208-44e9-4052-a56f-9a4cd9a5aaab2
349490ARIPiprazole 15 MG Oral TabletPSNd0640208-44e9-4052-a56f-9a4cd9a5aaab2
352308aripiprazole 15 MG Oral Tablet [Abilify]SBDd0640208-44e9-4052-a56f-9a4cd9a5aaab2
349490aripiprazole 15 MG Oral TabletSCDd0640208-44e9-4052-a56f-9a4cd9a5aaab2
352308Abilify 15 MG Oral TabletSYd0640208-44e9-4052-a56f-9a4cd9a5aaab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-009-135914800091330 TABLET in 1 BOTTLE, PLASTIC (59148-009-13) 30 tablet2002-11-150000-00-00NoNoCurrent
59148-009-3559148000935100 TABLET in 1 BLISTER PACK (59148-009-35) 100 tablet2002-11-150000-00-00NoNoCurrent
59148-009-95591480009957 TABLET in 1 BLISTER PACK (59148-009-95) 7 tablet2002-11-150000-00-00NoNoCurrent