LISINOPRIL

Product NDC: 55700-480
11-digit product format: 557000480
Labeler code: 55700
Product ID: 55700-480_d3848f99-9d73-431b-adb9-139152d78bbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA076164
Marketing category: ANDA
Marketing start: 2017-01-13
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-480		D	Discontinued by firm	2026-10-05
excluded package	package	55700-480	55700-480-30	D	Discontinued by firm	2026-10-05
excluded package	package	55700-480	55700-480-90	D	Discontinued by firm	2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-480	55700-480-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 7 · 243 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	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 243 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	A076164-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076164-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-006	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55700-480-30	LISINOPRIL	30 in 1 BOTTLE	TABLET	30		119
55700-480-90	LISINOPRIL	90 in 1 BOTTLE	TABLET	90		119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-480-30	EA - Each	55700-480	93e3ebb0-af4b-4d10-8676-bf96c2cb531e	1	2017-06-15
55700-480-90	EA - Each	55700-480	156563a3-0290-4bdc-a64a-1b5128247b20	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-480	LISINOPRIL TABLET [QUALITY CARE PRODUCTS LLC]	119	Legacy NDC, 2 package rows	20241219_babb75f0-bccc-44e8-955a-6873344ccc21.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 3 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	37aa2542-de44-401b-a6ff-96d2e07914c7	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Solco healthcare U.S., LLC	e299d477-a612-4af4-b6aa-f5addc8a736d	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	1ec55dd0-9ed5-40d2-978e-9fe773f2281a	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	6f7f5697-acb0-ea95-e053-2991aa0ae7c7	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	6314e49c-8715-2f01-e053-2a91aa0ab2a5	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5786b8d9-3818-66a5-e053-2991aa0a7025	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	51c80515-b26d-5776-e054-00144ff8d46c	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	54dc1e7e-6abd-4f6d-8b41-2b2731d51a65	2024-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3f6bc45e-448e-47f9-9bc4-991b1c503ddf	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3e4e69f6-b8a6-462d-a7ec-4cd6636512d0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Proficient Rx LP	06862c94-103d-4b12-8a74-abf52cb42389	2022-04-01	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	babb75f0-bccc-44e8-955a-6873344ccc21	119
314077	lisinopril 20 MG Oral Tablet	PSN	babb75f0-bccc-44e8-955a-6873344ccc21	119
314076	lisinopril 10 MG Oral Tablet	SCD	babb75f0-bccc-44e8-955a-6873344ccc21	119
314077	lisinopril 20 MG Oral Tablet	SCD	babb75f0-bccc-44e8-955a-6873344ccc21	119

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-480-30	55700048030	30 TABLET in 1 BOTTLE (55700-480-30)	30 tablet	2017-02-06	0000-00-00	No	No	Current
55700-480-90	55700048090	90 TABLET in 1 BOTTLE (55700-480-90)	90 tablet	2017-01-13	0000-00-00	No	No	Current