DAPIPRAZOLE

Product NDC: 53020-265
11-digit product format: 530200265
Labeler code: 53020
Product ID: 53020-265_14ba15fc-b733-44b1-a3ef-161654292782
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DAPIPRAZOLE
Dosage form: KIT
Labeler: Baradaina, LLC
Application: ANDA204902
Marketing category: ANDA
Marketing start: 2019-07-31
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53020-265		I	Inactivated by FDA		2026-08-17
excluded package	package	53020-265	53020-265-01	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204902-001	DAPIPRAZOLE HYDROCHLORIDE	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC			2019-05-30

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204902-001	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	2019-05-30	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
0a77f84f-9f13-4f19-a57a-ce66f11752cb	Product name	1	20190828
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53020-255-01	DAPIPRAZOLE	5 mL in 1 VIAL	POWDER, FOR SOLUTION	5 mL	25 mg in 5mL	3
53020-265-01	DAPIPRAZOLE	1 in 1 CARTON	KIT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53020-265	DAPIPRAZOLE KIT [BARADAINA, LLC]	3	Legacy NDC, 2 package rows	20240110_8b0fde24-9549-11cf-e053-2a95a90a9338.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5RNZ8GJO7K	DAPIPRAZOLE	72822-12-9	DAPIPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309649	dapiprazole HCl 0.5 % Ophthalmic Solution	PSN	8b0fde24-9549-11cf-e053-2a95a90a9338	3
309649	dapiprazole 5 MG/ML Ophthalmic Solution	SCD	8b0fde24-9549-11cf-e053-2a95a90a9338	3
309649	dapiprazole 0.5 % Ophthalmic Solution	SY	8b0fde24-9549-11cf-e053-2a95a90a9338	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53020-255-01	53020025501	5 mL in 1 VIAL	5 ml					Historical
53020-265-01	53020026501	1 KIT in 1 CARTON (53020-265-01) * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01)	1 kit	2019-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dapiprazole Hydrochloride Ophthalmic Solution, 0.5%	Baradaina, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3