Aripiprazole

Product NDC
70518-4745
Requested package NDC
70518-4745-0
11-digit product format
705184745
Labeler code
70518
Product ID
70518-4745_5afeb539-34e3-066d-e063-6394a90a3112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203908
Marketing category
ANDA
Marketing start
2026-09-08
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203908-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-10-08
A203908-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-10-08
A203908-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-10-08
A203908-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-10-08
A203908-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-10-08
A203908-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2015-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A203908-001AB
A203908-002AB
A203908-003AB
A203908-004AB
A203908-005AB
A203908-006AB

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.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-0884e616aacf4f…
2026-08-18 06:07:402026-07A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-10-08b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203908-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203908-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203908-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203908-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203908-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A203908-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A203908-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203908-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203908-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203908-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203908-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203908-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203908-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203908-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203908-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE15 mg/1

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
349490Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b72c0cff-9f4d-42e2-b884-d06dea3e6378Available on FDA.report

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.b72c0cff-9f4d-42e2-b884-d06dea3e63782026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
ndc (package): 70518-4745-0
ndc (product): 70518-4745
ndc11 (package): 70518474500
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsa8edb057-18a3-446d-8af0-672c97933a882025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack385301f5-e59d-42d5-8544-aadf0ee0c9672025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsc8a94428-b6d2-428b-a3a5-7b983d572fab2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEProficient Rx LPfbd81df7-8482-493e-bfc5-a3352f466b9e2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEProficient Rx LP19a3c2f2-11eb-4ec9-ac38-134168bdf99c2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908
AripiprazoleARIPIPRAZOLEProficient Rx LP11202c0a-7401-41c9-b1e7-d93739fcd36f2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203908
application number: ANDA203908

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4745-07051847450050 POUCH in 1 BOX (70518-4745-0) / 1 TABLET in 1 POUCH (70518-4745-1) 50 pouch2026-09-08NoNoCurrent