Lisinopril and Hydrochlorothiazide

Product NDC: 67046-0433
11-digit product format: 670460433
Labeler code: 67046
Product ID: 67046-0433_52b920c2-192d-0479-e063-6294a90aef9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA077912
Marketing category: ANDA
Marketing start: 2026-05-26
Substance: HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength: 12.5; 20 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27
A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27
A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2006-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077912-001	AB
A077912-002	AB
A077912-003	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 4 · 123 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	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A077912-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077912-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077912-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077912-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077912-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCHLOROTHIAZIDE	12.5 mg/1
LISINOPRIL	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
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
197886	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
52b90789-2902-3ab9-e063-6394a90a5abb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820	Product name	1	20230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
f65307a7-3644-0a09-cdfd-94aae8d3b53e	Product name	3	20210902
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-0433-3	Lisinopril and Hydrochlorothiazide	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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	3857ac53-0435-4d68-8066-c22291414889	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	868b1442-c412-4ee8-9798-f2408cd2249a	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	408e797a-2cf3-4ee6-9f9b-179a8cf3d799	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Coupler LLC	52b90789-2902-3ab9-e063-6394a90a5abb	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 67046-0433
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	5aa18b0b-4688-493a-a5ae-cb056ea6c0e3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	544b75eb-55f1-4164-9b83-39f6bc5fb479	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	019ac336-0dc3-ec89-3e0a-09110e0fc30b	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	eac8c44f-cf77-6a30-cfd7-7cffffc79bd6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	St Marys Medical Park Pharmacy	e7b68ea6-4fc8-441a-9640-1ccd3a482d8e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Legacy Pharmaceutical Packaging, LLC	6d729ec5-7311-4534-9999-9d6fa4f3ba2f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	8808879d-8c7e-45d1-8a49-c05d2cf845d3	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	00f67e1a-6999-4295-9c9f-fcb1ce9711b8	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	ec23c75d-68d5-46d0-be56-b96ddba19ed6	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2b94985-c79d-40e3-e053-2a95a90a0d78	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	c97e38f2-7163-4d4e-a694-4d0612423e53	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	3984e6b9-2d88-47f0-af09-cce428bba14f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	QPharma, Inc.	c80b2164-3795-6668-e053-2a95a90a4d45	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	515f735c-5dba-43d9-8a58-97a319cafd56	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	cd62e287-b648-459a-9414-621686c6b607	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	316e9226-e63e-466d-8143-f1edc7288fca	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
E7199S1YWR	LISINOPRIL	83915-83-7	LISINOPRIL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1162125	hydrochlorothiazide / lisinopril Pill	hydrochlorothiazide / lisinopril Pill	SCDG Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197886	lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	52b90789-2902-3ab9-e063-6394a90a5abb	1
197886	hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet	SCD	52b90789-2902-3ab9-e063-6394a90a5abb	1
197886	HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet	SY	52b90789-2902-3ab9-e063-6394a90a5abb	1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197886	lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	52b90789-2902-3ab9-e063-6394a90a5abb	1
197886	hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet	SCD	52b90789-2902-3ab9-e063-6394a90a5abb	1
197886	HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet	SY	52b90789-2902-3ab9-e063-6394a90a5abb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0433-3	67046043303	30 TABLET in 1 BLISTER PACK (67046-0433-3)	30 tablet	2026-05-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP	Coupler LLC \| LUPIN LIMITED	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1

Lisinopril and Hydrochlorothiazide

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Additional Listing Data#

Active Ingredients#

Harmonized UNII identifiers#

Harmonized RxCUI identifiers#

Harmonized SPL set identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#