benazepril hydrochloride and hydrochlorothiazide

Product NDC: 64980-194
Requested package NDC: 64980-194-01
11-digit product format: 649800194
Labeler code: 64980
Product ID: 64980-194_e7488c2e-9385-4ad1-b211-24adbbed407e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benazepril hydrochloride and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: NDA020033
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-03-20
Marketing end: 0000-00-00
Substance: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 10 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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64980-194	64980-194-01	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020033-001	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19
N020033-002	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19
N020033-003	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	RLD	1992-05-19
N020033-004	LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020033-002	AB
N020033-003	AB
N020033-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020033-001	LOTENSIN HCT	5MG;6.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-002	LOTENSIN HCT	10MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-003	LOTENSIN HCT	20MG;25MG	TABLET / ORAL	AB	RLD, RS	1992-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-004	LOTENSIN HCT	20MG;12.5MG	TABLET / ORAL	AB	RLD	1992-05-19	`d06236e962d9…`

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	N020033-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020033-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020033-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020033-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020033-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020033-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020033-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020033-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020033-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020033-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020033-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020033-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020033-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020033-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020033-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020033-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020033-002	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64980-194-01	2020-12-11	C162847	48780-1	9d75b9d0-900a-f424-e053-dadaa90a57ce	Benazepril HCl USP and Hydrochlorothiazide USP Tablets
64980-194-01	2020-01-31	C162847	48780-1	9d75b9d0-900a-f424-e053-dadaa90a57ce	Benazepril HCl USP and Hydrochlorothiazide USP Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-194-01	EA - Each	64980-194	e293e9e4-95b8-4a94-ba21-107a68674805	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMACEUTICALS, INC.]	2

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
Lotensin HCT	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Validus Pharmaceuticals LLC	94c4536f-e28e-48b1-8336-b3939917e99d	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Advagen Pharma Ltd	3f6e6da8-6da3-47c5-a151-e6fd7206890e	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f4120568-dd9b-47a5-bd44-4de6ed343bbe	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033
benazepril hydrochloride and hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	Padagis US LLC	3e2d3974-38b0-49d0-8020-f74107584724	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020033 application number: NDA020033

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-194-01	64980019401	100 TABLET in 1 BOTTLE (64980-194-01)	100 tablet	2014-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril HCl USP and Hydrochlorothiazide USP Tablets	Rising Pharmaceuticals, Inc. \| Halo Pharmaceuticals, Inc.	2018-09-18	Human Prescription Drug Label	7