FDA.reportPublic FDA data

ARIPIPRAZOLE

Product NDC
70752-114
11-digit product format
707520114
Labeler code
70752
Product ID
70752-114_f53a4fb5-9152-4ccc-82fb-f45ea242c03d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA215582
Marketing category
ANDA
Marketing start
2025-12-15
Substance
ARIPIPRAZOLE
Active strength
1 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215582-001ARIPIPRAZOLEARIPIPRAZOLE1MG/MLSOLUTION / ORALAA2025-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215582-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215582-001ARIPIPRAZOLE1MG/MLSOLUTION / ORALAA2025-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215582-001ARIPIPRAZOLE1MG/MLSOLUTION / ORALAA2025-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215582-001ARIPIPRAZOLE1MG/MLSOLUTION / ORALAA2025-10-2231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215582-001ARIPIPRAZOLE1MG/MLSOLUTION / ORALAA2025-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215582-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215582-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215582-001AA131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215582-001AA1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82VFR53I78Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485496Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b12f1ff2-c0b5-47e7-8075-bf2ce79fdaf8Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-114-07ARIPIPRAZOLE150 mL in 1 BOTTLESOLUTION1503
70752-114-07ARIPIPRAZOLE1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-114-07ML - Milliliter70752-114733a7553-ee1d-4eed-baab-88d51d42c56512026-01-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARIPIPRAZOLEARIPIPRAZOLEQUAGEN PHARMACEUTICALS LLCb12f1ff2-c0b5-47e7-8075-bf2ce79fdaf82025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215582
application number: ANDA215582
ndc (product): 70752-114

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSNb12f1ff2-c0b5-47e7-8075-bf2ce79fdaf83
485496aripiprazole 1 MG/ML Oral SolutionSCDb12f1ff2-c0b5-47e7-8075-bf2ce79fdaf83
485496aripiprazole 1 MG per 1 ML Oral SolutionSYb12f1ff2-c0b5-47e7-8075-bf2ce79fdaf83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-114-07707520114071 BOTTLE in 1 CARTON (70752-114-07) / 150 mL in 1 BOTTLE1 bottle2025-12-15NoNoCurrent