OPIPZA

Product NDC: 15370-402
11-digit product format: 153700402
Labeler code: 15370
Product ID: 15370-402_3dbb4e6d-14f0-4668-877c-2f4d9a94751f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARIPIPRAZOLE
Dosage form: FILM, SOLUBLE
Route: ORAL
Labeler: Carwin Pharmaceutical Associates, LLC
Application: NDA216655
Marketing category: NDA
Marketing start: 2024-11-01
Substance: ARIPIPRAZOLE
Active strength: 5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216655-001	OPIPZA	ARIPIPRAZOLE	2MG	FILM / ORAL	RLD	2024-07-22
N216655-002	OPIPZA	ARIPIPRAZOLE	5MG	FILM / ORAL	RLD	2024-07-22
N216655-003	OPIPZA	ARIPIPRAZOLE	10MG	FILM / ORAL	RLD, RS	2024-07-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216655-001	11331315	2040-11-03	Drug product	2024-11-12
N216655-001	11701352	2041-12-15	Drug product	2024-11-12
N216655-002	11331315	2040-11-03	Drug product	2024-11-12
N216655-002	11701352	2041-12-15	Drug product	2024-11-12
N216655-003	11331315	2040-11-03	Drug product	2024-11-12
N216655-003	11701352	2041-12-15	Drug product	2024-11-12

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	5 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
2697158	Internal RxNorm lookup
2697164	Internal RxNorm lookup
2697165	Internal RxNorm lookup
2697167	Internal RxNorm lookup
2697168	Internal RxNorm lookup
2697170	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
b47ede68-8942-4432-af7e-57afc14b2ba4	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	SPL version
15370-402-01	OPIPZA	1 in 1 POUCH	FILM, SOLUBLE	1	2
15370-402-30	OPIPZA	30 in 1 CARTON	FILM, SOLUBLE	30	2
15370-402-99	OPIPZA	2 in 1 CARTON	FILM, SOLUBLE	2	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15370-402-01	EA - Each	15370-402	33a27c0a-7ca5-4f41-b846-b5a99a758b2b	1	2025-02-10
15370-402-30	EA - Each	15370-402	7205a36d-8c0e-4f82-87d9-b9bb572f7553	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15370-402	OPIPZA (ARIPIPRAZOLE) FILM, SOLUBLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]	2	Current NDC, 3 package rows	20250131_b47ede68-8942-4432-af7e-57afc14b2ba4.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPIPZA	ARIPIPRAZOLE	Carwin Pharmaceutical Associates, LLC	b47ede68-8942-4432-af7e-57afc14b2ba4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216655 application number: NDA216655 ndc (product): 15370-402

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
2697168	ARIPiprazole 10 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697158	ARIPiprazole 2 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697165	ARIPiprazole 5 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697170	OPIPZA 10 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697164	OPIPZA 2 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697167	OPIPZA 5 MG Oral Film	PSN	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697170	aripiprazole 10 MG Oral Film [Opipza]	SBD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697164	aripiprazole 2 MG Oral Film [Opipza]	SBD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697167	aripiprazole 5 MG Oral Film [Opipza]	SBD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697168	aripiprazole 10 MG Oral Film	SCD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697158	aripiprazole 2 MG Oral Film	SCD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697165	aripiprazole 5 MG Oral Film	SCD	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697170	Opipza 10 MG Oral Film	SY	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697164	Opipza 2 MG Oral Film	SY	b47ede68-8942-4432-af7e-57afc14b2ba4	2
2697167	Opipza 5 MG Oral Film	SY	b47ede68-8942-4432-af7e-57afc14b2ba4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
15370-402-01	15370040201	1 in 1 POUCH					Historical
15370-402-30	15370040230	30 POUCH in 1 CARTON (15370-402-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01)	30 pouch	2024-11-01	No	No	Current
15370-402-99	15370040299	2 POUCH in 1 CARTON (15370-402-99) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01)	2 pouch	2025-01-28	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OPIPZA	Carwin Pharmaceutical Associates, LLC \| Xiamen LP Pharmaceutical Co., Ltd.	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	2