Lisinopril

Product NDC: 63187-442
11-digit product format: 631870442
Labeler code: 63187
Product ID: 63187-442_74611f00-d9a2-44c0-952f-5ca7cbc39a34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076059
Marketing category: ANDA
Marketing start: 2002-07-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076059-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A076059-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A076059-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A076059-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A076059-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A076059-006	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
A076059-001	AB
A076059-002	AB
A076059-003	AB
A076059-004	AB
A076059-005	AB
A076059-006	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 · 252 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
2026-08-18 06:07:40	2026-07	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076059-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076059-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076059-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-004	AB	1	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	20 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
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
8a14eaa6-cb8b-4088-ba15-840b587ab1f7	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	SPL version
63187-442-00	Lisinopril	100 in 1 BOTTLE, PLASTIC	TABLET	100	6
63187-442-30	Lisinopril	30 in 1 BOTTLE, PLASTIC	TABLET	30	6
63187-442-60	Lisinopril	60 in 1 BOTTLE, PLASTIC	TABLET	60	6
63187-442-90	Lisinopril	90 in 1 BOTTLE, PLASTIC	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-442-00	EA - Each	63187-442	8d8e5d49-0c19-48c4-950a-79c733fa919c	1	2021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL TABLET [PROFICIENT RX LP]	1
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL TABLET [PROFICIENT RX LP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LISINOPRIL TABLET [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	LISINOPRIL TABLET [PROFICIENT RX LP]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LISINOPRIL TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL TABLET [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-442	LISINOPRIL TABLET [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 4 package rows	20220421_8a14eaa6-cb8b-4088-ba15-840b587ab1f7.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	QPharma Inc	b17cd16b-8d0a-4cfa-bd48-2529983fcd12	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	964c7f28-f62e-30b5-e053-2a95a90ab84c	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	33ebf3f2-cd71-4d8b-ac22-1a20a068a13d	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	ab9bc1b4-60cc-76ea-e053-2995a90ac203	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	90a589a9-acc2-bfbe-e053-2995a90a0bd2	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	95376981-4620-c9aa-e053-2995a90a1390	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	3783ab4c-2bed-414e-8927-62d47e3e3496	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	5af2444f-438c-4ea6-96e8-3dba1af9e1a5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Proficient Rx LP	8a14eaa6-cb8b-4088-ba15-840b587ab1f7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 63187-442
Lisinopril	LISINOPRIL	Proficient Rx LP	55a57d80-6bed-44a3-b3ea-6bb44c34cbfc	2021-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Actavis Pharma, Inc.	43e2c8d1-3704-4323-bcaf-f582572b81f7	2017-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059

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
314077	lisinopril 20 MG Oral Tablet	PSN	8a14eaa6-cb8b-4088-ba15-840b587ab1f7	6
314077	lisinopril 20 MG Oral Tablet	SCD	8a14eaa6-cb8b-4088-ba15-840b587ab1f7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-442-00	63187044200	100 TABLET in 1 BOTTLE, PLASTIC (63187-442-00)	100 tablet	2021-02-10	0000-00-00	No	No	Current
63187-442-30	63187044230	30 TABLET in 1 BOTTLE, PLASTIC (63187-442-30)	30 tablet	2014-03-04	0000-00-00	No	No	Current
63187-442-60	63187044260	60 TABLET in 1 BOTTLE, PLASTIC (63187-442-60)	60 tablet	2021-02-10	0000-00-00	No	No	Current
63187-442-90	63187044290	90 TABLET in 1 BOTTLE, PLASTIC (63187-442-90)	90 tablet	2014-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ONCE-DAILY Lisinopril Tablets USP Revised: January 2014 Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	6