Lisinopril

Product NDC: 72865-208
Requested package NDC: 72865-208-05
11-digit product format: 728650208
Labeler code: 72865
Product ID: 72865-208_c008ecb6-970d-4ac9-9402-e21e8d9d76b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: XLCare Pharmaceuticals Inc.
Application: ANDA075903
Marketing category: ANDA
Marketing start: 2021-08-17
Substance: LISINOPRIL
Active strength: 2.5 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

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
A075903-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A075903-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A075903-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A075903-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A075903-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A075903-006	LISINOPRIL	LISINOPRIL	40MG	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
A075903-001	AB
A075903-002	AB
A075903-003	AB
A075903-004	AB
A075903-005	AB
A075903-006	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 · 246 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	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 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	A075903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075903-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075903-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075903-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075903-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075903-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075903-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075903-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	2.5 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197884	Internal RxNorm lookup
205326	Internal RxNorm lookup
311353	Internal RxNorm lookup
311354	Internal RxNorm lookup
314076	Internal RxNorm lookup
314077	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
c008ecb6-970d-4ac9-9402-e21e8d9d76b2	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
72865-208-01	Lisinopril	100 in 1 BOTTLE	TABLET	100		1
72865-208-05	Lisinopril	500 in 1 BOTTLE	TABLET	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72865-208	LISINOPRIL TABLET [XLCARE PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20211023_c008ecb6-970d-4ac9-9402-e21e8d9d76b2.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	Legacy Pharmaceutical Packaging, LLC	f5db9549-e179-3db6-e053-2995a90a1544	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075903 application number: ANDA075903
Lisinopril	LISINOPRIL	Camber Pharmaceuticals, Inc.	387068e7-7fb9-44f3-ae1c-e45ebc755a3e	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075903 application number: ANDA075903
Lisinopril	LISINOPRIL	Camber Pharmaceuticals, Inc.	8f20acd7-2635-4a9b-b732-2a84ea93dea7	2021-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075903 application number: ANDA075903
Lisinopril	LISINOPRIL	XLCare Pharmaceuticals Inc.	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	2021-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075903 application number: ANDA075903 ndc (package): 72865-208-05 ndc (product): 72865-208 ndc11 (package): 72865020805

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	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
311353	lisinopril 2.5 MG Oral Tablet	PSN	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
314077	lisinopril 20 MG Oral Tablet	PSN	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
205326	lisinopril 30 MG Oral Tablet	PSN	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
197884	lisinopril 40 MG Oral Tablet	PSN	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
311354	lisinopril 5 MG Oral Tablet	PSN	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
314076	lisinopril 10 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
311353	lisinopril 2.5 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
314077	lisinopril 20 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
205326	lisinopril 30 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
197884	lisinopril 40 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1
311354	lisinopril 5 MG Oral Tablet	SCD	c008ecb6-970d-4ac9-9402-e21e8d9d76b2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72865-208-05	72865020805	500 TABLET in 1 BOTTLE (72865-208-05)	500 tablet	2021-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lisinopril	XLCare Pharmaceuticals Inc. \| Evaric Pharmaceuticals Inc	2021-09-23	Human Prescription Drug Label	1