Aripiprazole

Product NDC
29300-179
11-digit product format
293000179
Labeler code
29300
Product ID
29300-179_f1daa6df-15e5-4f75-b656-6f99906e98e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA203025
Marketing category
ANDA
Marketing start
2022-02-21
Substance
ARIPIPRAZOLE
Active strength
20 mg/1
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 1.

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
A203025-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2021-12-01
A203025-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2021-12-01
A203025-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2021-12-01
A203025-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2021-12-01
A203025-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2021-12-01
A203025-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2021-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203025-001AB
A203025-002AB
A203025-003AB
A203025-004AB
A203025-005AB
A203025-006AB

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 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-005ARIPIPRAZOLE20MGTABLET / ORALAB2021-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-006ARIPIPRAZOLE30MGTABLET / ORALAB2021-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-001ARIPIPRAZOLE2MGTABLET / ORALAB2021-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-002ARIPIPRAZOLE5MGTABLET / ORALAB2021-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-003ARIPIPRAZOLE10MGTABLET / ORALAB2021-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-004ARIPIPRAZOLE15MGTABLET / ORALAB2021-12-012680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203025-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203025-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203025-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203025-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203025-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203025-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203025-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203025-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203025-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE20 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349490Internal RxNorm lookup
349545Internal RxNorm lookup
349547Internal RxNorm lookup
349553Internal RxNorm lookup
402131Internal RxNorm lookup
602964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
349b8a7b-5ada-4f5c-a269-a86806c6b520Available 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
29300-179-01Aripiprazole100 in 1 BOTTLE, PLASTICTABLET10013
29300-179-05Aripiprazole500 in 1 BOTTLE, PLASTICTABLET50013
29300-179-13Aripiprazole30 in 1 BOTTLE, PLASTICTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-179-13EA - Each29300-17955a1deab-b680-4b08-b1ff-8ccf8c61a8fc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-179ARIPIPRAZOLE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]13Current NDC, Legacy NDC, 3 package rows20250226_349b8a7b-5ada-4f5c-a269-a86806c6b520.zip

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
AripiprazoleARIPIPRAZOLEUnichem Pharmaceuticals (USA), Inc.349b8a7b-5ada-4f5c-a269-a86806c6b5202025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203025
application number: ANDA203025
ndc (product): 29300-179

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
349490ARIPiprazole 15 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
602964ARIPiprazole 2 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
349553ARIPiprazole 20 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
349547ARIPiprazole 30 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
402131ARIPiprazole 5 MG Oral TabletPSN349b8a7b-5ada-4f5c-a269-a86806c6b52013
349545aripiprazole 10 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013
349490aripiprazole 15 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013
602964aripiprazole 2 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013
349553aripiprazole 20 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013
349547aripiprazole 30 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013
402131aripiprazole 5 MG Oral TabletSCD349b8a7b-5ada-4f5c-a269-a86806c6b52013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-179-0129300017901100 TABLET in 1 BOTTLE, PLASTIC (29300-179-01) 100 tablet2022-02-210000-00-00NoNoCurrent
29300-179-0529300017905500 TABLET in 1 BOTTLE, PLASTIC (29300-179-05) 500 tablet2022-02-210000-00-00NoNoCurrent
29300-179-132930001791330 TABLET in 1 BOTTLE, PLASTIC (29300-179-13) 30 tablet2022-02-210000-00-00NoNoCurrent