Quinapril HCL and Hydrochlorothiazide

Product NDC: 43386-710
11-digit product format: 433860710
Labeler code: 43386
Product ID: 43386-710_916f3e69-0d6e-4524-8abe-afb2e134eec2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quinapril HCl and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA076374
Marketing category: ANDA
Marketing start: 2011-07-15
Substance: QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 10; 12.5 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31
A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31
A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076374-001	AB
A076374-002	AB
A076374-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL		2004-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB	2004-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	2004-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL		2004-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL		2004-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076374-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076374-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL		2004-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076374-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL		2004-03-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076374-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076374-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076374-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076374-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076374-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076374-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076374-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076374-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076374-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076374-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076374-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076374-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076374-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076374-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076374-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076374-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076374-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076374-003	AB	1	`d8e5a09893c0…`
2022-04-08 23:34 UTC	2022-04	A076374-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076374-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076374-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076374-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076374-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076374-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076374-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076374-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076374-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076374-001	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Quinapril HCL and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUINAPRIL HYDROCHLORIDE	10 mg/1
HYDROCHLOROTHIAZIDE	12.5 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
33067B3N2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310796	Internal RxNorm lookup
310797	Internal RxNorm lookup
310809	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
383ecaa6-29c8-4280-a442-c47f101d7c88	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
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
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
9992a562-005f-c280-535c-2e4eaa81efcd	Product name	2	20161121
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
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	SPL version
43386-710-03	Quinapril HCL and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	9
43386-710-05	Quinapril HCL and Hydrochlorothiazide	500 in 1 BOTTLE	TABLET	500	9
43386-710-09	Quinapril HCL and Hydrochlorothiazide	90 in 1 BOTTLE	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-710-05	EA - Each	43386-710	8983366c-3cb0-4863-8275-f707aac8a60e	1	2012-07-24
43386-710-09	EA - Each	43386-710	35951031-a43f-4836-a845-93b71e68995d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-710	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS,INC.]	9	Current NDC, Legacy NDC, 3 package rows	20240131_383ecaa6-29c8-4280-a442-c47f101d7c88.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinapril HCL and Hydrochlorothiazide	QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals,Inc.	383ecaa6-29c8-4280-a442-c47f101d7c88	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076374 application number: ANDA076374 ndc (product): 43386-710
Quinapril and Hydrochlorothiazide	QUINAPRIL AND HYDROCHLOROTHIAZIDE	Chartwell RX, LLC	2eae533f-d0af-47e8-a1f2-94bc8cc89b5a	2023-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076374 application number: ANDA076374

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33067B3N2M	QUINAPRIL HYDROCHLORIDE	82586-55-8	QUINAPRIL HYDROCHLORIDE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310796	quinapril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310797	quinapril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310809	quinapril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310796	hydrochlorothiazide 12.5 MG / quinapril 10 MG Oral Tablet	SCD	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310797	hydrochlorothiazide 12.5 MG / quinapril 20 MG Oral Tablet	SCD	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310809	hydrochlorothiazide 25 MG / quinapril 20 MG Oral Tablet	SCD	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310796	HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 10 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310797	HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 20 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310796	HCTZ 12.5 MG / quinapril 10 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310797	HCTZ 12.5 MG / quinapril 20 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310809	HCTZ 25 MG / quinapril (as quinapril hydrochloride) 20 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9
310809	HCTZ 25 MG / quinapril 20 MG Oral Tablet	SY	383ecaa6-29c8-4280-a442-c47f101d7c88	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-710-03	43386071003	30 TABLET in 1 BOTTLE (43386-710-03)	30 tablet	2012-06-18	0000-00-00	No	No	Current
43386-710-05	43386071005	500 TABLET in 1 BOTTLE (43386-710-05)	500 tablet	2011-07-15	0000-00-00	No	No	Current
43386-710-09	43386071009	90 TABLET in 1 BOTTLE (43386-710-09)	90 tablet	2011-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quinapril and Hydrochlorothiazide Tablet, USP Rx only	Lupin Pharmaceuticals,Inc. \| Lupin Inc. \| Novel Laboratories, Inc.	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	9