LISINOPRIL

Product NDC: 16729-376
Requested package NDC: 16729-376-17
11-digit product format: 167290376
Labeler code: 16729
Product ID: 16729-376_ecb64f83-e355-31a4-e053-2a95a90a4071
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA202554
Marketing category: ANDA
Marketing start: 2016-06-02
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16729-376	16729-376-17	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A202554-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30
A202554-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30
A202554-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30
A202554-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30
A202554-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30
A202554-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A202554-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202554-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202554-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202554-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202554-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202554-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202554-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202554-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202554-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202554-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202554-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202554-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202554-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202554-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202554-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202554-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202554-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202554-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202554-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202554-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202554-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202554-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202554-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202554-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202554-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202554-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202554-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202554-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202554-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202554-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202554-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202554-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202554-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202554-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202554-004	AB	1	`782e0a99824c…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-376-17	EA - Each	16729-376	5d234377-05ff-4eff-88c6-7924a0c1cef8	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL TABLET [ACCORD HEALTHCARE INC.]	4

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
311354	lisinopril 5 MG Oral Tablet	PSN	3aac424f-d99c-5248-e054-00144ff8d46c	4
311354	lisinopril 5 MG Oral Tablet	SCD	3aac424f-d99c-5248-e054-00144ff8d46c	4
311354	lisinopril 5 MG Oral Tablet	PSN	052468a2-56df-4641-a343-3733f3ebe66e	3
311354	lisinopril 5 MG Oral Tablet	SCD	052468a2-56df-4641-a343-3733f3ebe66e	3
311354	lisinopril 5 MG Oral Tablet	PSN	44571f77-6bb0-3885-e054-00144ff88e88	2
311354	lisinopril 5 MG Oral Tablet	SCD	44571f77-6bb0-3885-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-376-17	16729037617	1000 TABLET in 1 BOTTLE (16729-376-17)	1000 tablet	2016-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LISINOPRIL	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	10
LISINOPRIL	Preferred Pharmaceuticals Inc.	2021-07-07	HUMAN PRESCRIPTION DRUG LABEL	6
LISINOPRIL	NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
LISINOPRIL - DIRECT RX	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
LISINOPRIL	Unit Dose Services	2017-02-27	HUMAN PRESCRIPTION DRUG LABEL	3