Benazepril Hydrochloride and Hydrochlorothiazide

Product NDC: 68462-577
Requested package NDC: 68462-577-01
11-digit product format: 684620577
Labeler code: 68462
Product ID: 68462-577_51b0aed8-a229-4d2c-8fdf-aa957fddc41b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA076631
Marketing category: ANDA
Marketing start: 2014-04-04
Substance: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 10; 12.5 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], 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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11
A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11
A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11
A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RS	2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076631-001	AB
A076631-002	AB
A076631-003	AB
A076631-004	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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RS	2004-02-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RS	2004-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RS	2004-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RS	2004-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076631-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB		2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076631-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076631-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076631-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB		2004-02-11	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 5 · 167 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A076631-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076631-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076631-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076631-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076631-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076631-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076631-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076631-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076631-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076631-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076631-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076631-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076631-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076631-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076631-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076631-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076631-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076631-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076631-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076631-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076631-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076631-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076631-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076631-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076631-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076631-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076631-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076631-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076631-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076631-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076631-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076631-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076631-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076631-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076631-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076631-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076631-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076631-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076631-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076631-004	AB	1	`e64feba35796…`

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: Benazepril Hydrochloride and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENAZEPRIL 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
N1SN99T69T	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
898362	Internal RxNorm lookup
898367	Internal RxNorm lookup
898372	Internal RxNorm lookup
898378	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
51b0aed8-a229-4d2c-8fdf-aa957fddc41b	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
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
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
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4	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
68462-577-01	Benazepril Hydrochloride and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-577-01	EA - Each	68462-577	2b1eea72-0167-4199-8188-2a8995d04694	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-577	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	1	Current NDC, 1 package rows	20231202_51b0aed8-a229-4d2c-8fdf-aa957fddc41b.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
Benazepril Hydrochloride and Hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Sandoz Inc	c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f	2025-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076631 application number: ANDA076631
Benazepril Hydrochloride and Hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Glenmark Pharmaceuticals Inc., USA	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076631 application number: ANDA076631 ndc (package): 68462-577-01 ndc (product): 68462-577 ndc11 (package): 68462057701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N1SN99T69T	BENAZEPRIL HYDROCHLORIDE	86541-74-4	BENAZEPRIL HYDROCHLORIDE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
898362	benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898367	benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898372	benazepril HCl 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898378	benazepril HCl 5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet	PSN	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898362	benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898367	benazepril hydrochloride 20 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898372	benazepril hydrochloride 20 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898378	benazepril hydrochloride 5 MG / hydrochlorothiazide 6.25 MG Oral Tablet	SCD	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898362	benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898367	benazepril hydrochloride 20 MG / HCTZ 12.5 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898372	benazepril hydrochloride 20 MG / HCTZ 25 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898378	benazepril hydrochloride 5 MG / HCTZ 6.25 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898362	BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898367	BZP hydrochloride 20 MG / HCTZ 12.5 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898372	BZP hydrochloride 20 MG / HCTZ 25 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1
898378	BZP hydrochloride 5 MG / HCTZ 6.25 MG Oral Tablet	SY	51b0aed8-a229-4d2c-8fdf-aa957fddc41b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68462-577-01	68462057701	100 TABLET, FILM COATED in 1 BOTTLE (68462-577-01)	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril Hydrochloride and Hydrochlorothiazide Tablets, USP Rx Only	Glenmark Pharmaceuticals Inc., USA	2023-09-30	HUMAN PRESCRIPTION DRUG LABEL	1