LISINOPRIL

Product NDC: 68071-1672
11-digit product format: 680711672
Labeler code: 68071
Product ID: 68071-1672_1d4e3508-f3b0-3203-e063-6294a90addb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA076180
Marketing category: ANDA
Marketing start: 2011-11-01
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: 2026-12-31
Current FDA listing: Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1672-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1672-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1672-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1672-1	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076180-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: LISINOPRIL
Listing expiration: 2026-12-31

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
5a1c5b04-b78c-c057-e053-2991aa0aa916	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-15	These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
2023-01-30	These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
2021-02-11	These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
2021-01-29	These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1672-1	LISINOPRIL	100 in 1 BOTTLE	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1672	LISINOPRIL TABLET [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240716_5a1c5b04-b78c-c057-e053-2991aa0aa916.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6051cc96-86e0-bd0b-e053-2a91aa0a5dcf	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	42f49299-7ae5-4d30-86eb-66b739c0e95d	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6062fd98-7663-f4b5-e053-2a91aa0acbc3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	7e297133-669e-4780-a966-c777624e5427	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	affd3e43-077e-42e5-a865-c961624bfe93	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals, Inc.	74415f95-74c9-4329-a6af-a0f165bf7887	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Quality Care Products LLC	babb75f0-bccc-44e8-955a-6873344ccc21	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4f1f76fe-816c-384a-e054-00144ff88e88	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa518e1-d989-1fde-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa44af9-1aff-314c-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5a1c5b04-b78c-c057-e053-2991aa0aa916	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-1672
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	9148529f-6278-e507-e053-2995a90aa4cf	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	86e7a336-c416-6fab-e053-2a91aa0a274c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Proficient Rx LP	e5fbefd1-4077-4e81-a0e3-e09fadc48593	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	b5683ac4-59dc-4772-8bc6-984c698afbeb	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	2dbec080-a266-4317-8d4b-b4046206416e	2022-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	6ba2c7d6-bc9e-4d8b-8d1e-c14004750693	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180

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	5a1c5b04-b78c-c057-e053-2991aa0aa916	5
314076	lisinopril 10 MG Oral Tablet	SCD	5a1c5b04-b78c-c057-e053-2991aa0aa916	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1672-1	68071167201	100 TABLET in 1 BOTTLE (68071-1672-1)	100 tablet	2017-09-26	0000-00-00	No	No	Current