LISINOPRIL

Product NDC: 53002-1463
Requested package NDC: 53002-1463-3
11-digit product format: 530021463
Labeler code: 53002
Product ID: 53002-1463_fe7c7b6c-e0da-4802-9af0-d84dca3d2eb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA076164
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1463	53002-1463-3	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A076164-001	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A076164-002	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A076164-003	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01
A076164-004	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A076164-005	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A076164-006	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076164-001	AB
A076164-002	AB
A076164-003	AB
A076164-004	AB
A076164-005	AB
A076164-006	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 6 · 231 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
2026-02-19 14:30 UTC	2026-02	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 231 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076164-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076164-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076164-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076164-004	AB	1	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820	Product name	1	20230703
f65307a7-3644-0a09-cdfd-94aae8d3b53e	Product name	3	20210902
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1463-0	2025-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-3	2025-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-6	2025-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-0	2023-06-07	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-3	2023-06-07	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-6	2023-06-07	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-0	2023-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-3	2023-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-6	2023-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-0	2020-12-16	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-3	2020-12-16	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-6	2020-12-16	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-0	2020-01-31	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-3	2020-01-31	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
53002-1463-6	2020-01-31	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1463-0	LISINOPRIL	100 in 1 BOTTLE	TABLET	100	14
53002-1463-3	LISINOPRIL	30 in 1 BOTTLE	TABLET	30	14
53002-1463-6	LISINOPRIL	60 in 1 BOTTLE	TABLET	60	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1463	LISINOPRIL TABLET [RPK PHARMACEUTICALS, INC.]	14	Legacy NDC, 3 package rows	20230609_9c03eb4a-aa58-44a8-82d4-669c880a6f45.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 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	12d6fe7e-b5a2-4d49-9a06-a6150234d061	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Coupler LLC	560513ef-4d2c-8ca0-e063-6394a90a674a	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	e17bcc2e-f5ed-4846-95d3-a5479c7fee8d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	5f4c1a62-fb84-8cdc-e053-2a91aa0a671a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	5eff766f-82e2-4cd6-e053-2a91aa0a4782	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4b6dc0d4-4acd-3606-e054-00144ff8d46c	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	ab561d21-7466-4d8b-8d06-291c1d4d82ff	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	02c23f9c-f3cf-4366-ae1e-56296f1fedf9	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	f57bd658-05d8-475a-ae74-87d2c7866417	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	bd804d65-742a-4890-ac9d-bee69968387d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	11a83bbc-9871-4df8-b3f2-7aba5149f3fe	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Proficient Rx LP	eddec313-910c-4bf1-9095-2153db53bc6e	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Proficient Rx LP	350c6fc9-9774-4d49-9242-19e96944f83b	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	d18f2117-0d2a-4e0d-8ffb-130ca6900364	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	RedPharm Drug, Inc.	4f08cfc9-7afc-33aa-e054-00144ff88e88	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Northwind Health Company, LLC	ab2f8ab5-3c87-484a-e053-2995a90a42bb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Northwind Health Company, LLC	ae2cdf9b-e71e-8315-e053-2995a90a5310	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Northwind Health Company, LLC	dac0c8f1-e3cf-11e6-e053-2a95a90adbcb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Northwind Health Company, LLC	ae2d9df4-29ce-3d07-e053-2995a90ab184	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E7199S1YWR	LISINOPRIL	83915-83-7	LISINOPRIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314076	lisinopril 10 MG Oral Tablet	PSN	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
314077	lisinopril 20 MG Oral Tablet	PSN	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
197884	lisinopril 40 MG Oral Tablet	PSN	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
311354	lisinopril 5 MG Oral Tablet	PSN	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
314076	lisinopril 10 MG Oral Tablet	SCD	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
314077	lisinopril 20 MG Oral Tablet	SCD	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
197884	lisinopril 40 MG Oral Tablet	SCD	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14
311354	lisinopril 5 MG Oral Tablet	SCD	9c03eb4a-aa58-44a8-82d4-669c880a6f45	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1463-3	53002146303	30 TABLET in 1 BOTTLE (53002-1463-3)	30 tablet	2017-09-01	0000-00-00	No	No	Current