Lisinopril

Product NDC: 70518-4397
11-digit product format: 705184397
Labeler code: 70518
Product ID: 70518-4397_5b20e6c0-d339-c3bc-e063-6394a90a2d02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077321
Marketing category: ANDA
Marketing start: 2025-07-23
Substance: LISINOPRIL
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A077321-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09
A077321-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09
A077321-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09
A077321-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09
A077321-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09
A077321-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077321-001	AB
A077321-002	AB
A077321-003	AB
A077321-004	AB
A077321-005	AB
A077321-006	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 · 258 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	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A077321-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lisinopril
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E7199S1YWR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314076	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
aa5d68e7-c2b9-41eb-ade4-2cd57edc1533	Available on FDA.report

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
70518-4397-0	Lisinopril	30 in 1 BLISTER PACK	TABLET	30		1

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	efc9eb3c-0f54-47b8-b236-8680e0046ea4	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	03fe066f-c3d7-fa71-e063-6294a90ac6f6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	f2b42895-ae25-2d2b-e053-2995a90a899a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	c16edad6-423b-6ff0-e053-2a95a90a0240	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	6515d800-be95-4a70-ab1e-b4000708dd20	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	e3b14778-a57e-51d5-e053-2a95a90a9aad	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	e3b29545-6ba5-6bf5-e053-2995a90ae7de	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Northwind Health Company, LLC	f7f78491-bb4f-7ae7-e053-6394a90aff6f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	QPharma, Inc.	e56f3738-3103-3ba4-e053-2a95a90aebb4	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	QPharma, Inc.	f6f68322-f8a1-9011-e053-6394a90a1d2c	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	QPharma, Inc.	fbbff4eb-a641-b083-e053-6294a90a404a	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	American Health Packaging	a2f31909-3cda-4580-adfa-e9992d8c0885	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	6292f329-803b-4421-adda-63fad1a0a29f	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Lupin Pharmaceuticals, Inc.	7d6c31e2-b5a4-4279-8013-a8dad37ea73b	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	47054448-7d5f-43c4-8313-70179a7f9a2e	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Major Pharmaceuticals	faade1f8-f901-40f9-a5a2-2a00e8aa94d1	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	cced442b-8047-4489-95d6-0700a66fba34	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	fbd3bde1-ee64-126f-e053-6394a90a9b6d	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	fbfa23c2-dae0-4f45-e053-6394a90a4fef	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	9ba3610b-de5c-fa33-e053-2a95a90acbc5	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321

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	aa5d68e7-c2b9-41eb-ade4-2cd57edc1533	1
314076	lisinopril 10 MG Oral Tablet	SCD	aa5d68e7-c2b9-41eb-ade4-2cd57edc1533	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4397-0	70518439700	30 TABLET in 1 BLISTER PACK (70518-4397-0)	30 tablet	2025-07-23	No	No	Current