Aripiprazole

Product NDC: 16714-145
Requested package NDC: 16714-145-01
11-digit product format: 167140145
Labeler code: 16714
Product ID: 16714-145_04230bfc-e6ad-1844-e063-6394a90a939e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA205064
Marketing category: ANDA
Marketing start: 2020-10-01
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205064-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A205064-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A205064-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A205064-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A205064-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A205064-006	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
A205064-001	AB
A205064-002	AB
A205064-003	AB
A205064-004	AB
A205064-005	AB
A205064-006	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A205064-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205064-006	AB	1	`a50c72e98297…`

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	414b7fd2-6a63-af39-e063-6394a90a00b8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0cf6655e-d59a-4ebd-9698-195cad2adbd5	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	AvPAK	7df4c83e-13d8-25b1-57eb-08d26ba03565	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	3cf72cc6-ae43-bfd5-e063-6294a90a18b0	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	American Health Packaging	80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals,Inc.	3726d102-dd9f-645e-e063-6294a90aeb9e	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f823bc23-27f3-2397-e053-6294a90a365a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	89c2cddc-2ae3-4505-adf9-018542c713bf	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	3c0109f6-0549-4f91-a259-d9d6d7329b91	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	6b0c3767-d397-4c7f-b229-083620d9ae6b	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NorthStar RxLLC	f87dbfe4-5417-47c9-a97f-d246cfc10023	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (package): 16714-145-01 ndc (product): 16714-145 ndc11 (package): 16714014501
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	0a6fa113-6bb2-4f88-af07-ce0914c98ff2	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	b284b294-40a0-4ccd-b7b7-b61267cd4e76	2023-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Exelan Pharmaceuticals, Inc.	705190bf-9f9d-4183-a56b-4eeafeacde59	2018-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
ARIPIPRAZOLE	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	3718e585-06b9-40fd-a3eb-18b6497a4235	2017-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064

Additional Listing Data#

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

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349490	Internal RxNorm lookup
349545	Internal RxNorm lookup
349547	Internal RxNorm lookup
349553	Internal RxNorm lookup
402131	Internal RxNorm lookup
602964	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
f87dbfe4-5417-47c9-a97f-d246cfc10023	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
16714-145-01	Aripiprazole	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-145-01	EA - Each	16714-145	4952b739-ff2d-4d15-b9aa-973b2d9616cf	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-145	ARIPIPRAZOLE (ARIPIPRAZOLE) TABLET [NORTHSTAR RXLLC]	2	Current NDC, Legacy NDC, 1 package rows	20230831_f87dbfe4-5417-47c9-a97f-d246cfc10023.zip

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
349545	ARIPiprazole 10 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349490	ARIPiprazole 15 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
602964	ARIPiprazole 2 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349553	ARIPiprazole 20 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349547	ARIPiprazole 30 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
402131	ARIPiprazole 5 MG Oral Tablet	PSN	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349545	aripiprazole 10 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349490	aripiprazole 15 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
602964	aripiprazole 2 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349553	aripiprazole 20 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349547	aripiprazole 30 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
402131	aripiprazole 5 MG Oral Tablet	SCD	f87dbfe4-5417-47c9-a97f-d246cfc10023	2
349553	ARIPiprazole 20 MG Oral Tablet	PSN	89c2cddc-2ae3-4505-adf9-018542c713bf	1
349553	aripiprazole 20 MG Oral Tablet	SCD	89c2cddc-2ae3-4505-adf9-018542c713bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-145-01	16714014501	30 TABLET in 1 BOTTLE (16714-145-01)	30 tablet	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aripiprazole	A-S Medication Solutions	2024-04-11	HUMAN PRESCRIPTION DRUG LABEL	1
Aripiprazole	NorthStar RxLLC \| Hetero Labs Limited Unit V	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	2