Aripiprazole

Product NDC: 67046-1085
Requested package NDC: 67046-1085-3
11-digit product format: 670461085
Labeler code: 67046
Product ID: 67046-1085_52cccece-83a4-0620-e063-6294a90a1be7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA202101
Marketing category: ANDA
Marketing start: 2026-05-27
Substance: ARIPIPRAZOLE
Active strength: 20 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202101-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A202101-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A202101-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A202101-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A202101-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A202101-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202101-001	AB
A202101-002	AB
A202101-003	AB
A202101-004	AB
A202101-005	AB
A202101-006	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202101-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202101-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202101-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202101-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202101-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202101-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-004	AB	1	`b8a1b40f171c…`

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
Ingredient	Strength
ARIPIPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82VFR53I78	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349553	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
52cc86ba-2c4f-1aba-e063-6294a90a844e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
915afeb5-0b22-42c0-86ea-77abf1c5fe15	Product name	1	20250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6e	Product name	1	20231010
34645f32-2ac4-41bf-9c61-8107e4764a26	Product name	1	20181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d	Product name	1	20180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02	Product name	1	20170824
8223ef47-de85-24dd-a9c7-5a041d2634a2	Product name	9	20170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1085-3	Aripiprazole	30 in 1 BLISTER PACK	TABLET	30		1

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	119e3387-39a2-4fe5-904b-c2d008425c0a	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	99747897-22fe-4bee-9942-6349c0c8f6b0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	56439ef6-a07e-34c9-e063-6294a90a77c3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52cc86ba-2c4f-1aba-e063-6294a90a844e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101 ndc (package): 67046-1085-3 ndc (product): 67046-1085 ndc11 (package): 67046108503
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	512874e6-6d00-2623-e063-6394a90aa4bc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	02a4af27-c83c-4166-950c-7a1cb12d198d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	a10a5427-58b1-42dd-964c-3f8c78770534	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	793fc904-2f11-4f97-a0ac-4d6910cac0f9	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82VFR53I78	ARIPIPRAZOLE	129722-12-9	ARIPIPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349553	ARIPiprazole 20 MG Oral Tablet	PSN	52cc86ba-2c4f-1aba-e063-6294a90a844e	1
349553	aripiprazole 20 MG Oral Tablet	SCD	52cc86ba-2c4f-1aba-e063-6294a90a844e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1085-3	67046108503	30 TABLET in 1 BLISTER PACK (67046-1085-3)	30 tablet	2026-05-27	No	No	Current