Captopril and Hydrochlorothiazide

Product NDC: 0378-0081
Requested package NDC: 0378-0081-01
11-digit product format: 003780081
Labeler code: 0378
Product ID: 0378-0081_2a59df64-9cc5-4f53-bb80-4d09ca5416c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: captopril and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074896
Marketing category: ANDA
Marketing start: 1997-12-29
Marketing end: 0000-00-00
Substance: CAPTOPRIL; HYDROCHLOROTHIAZIDE
Active strength: 25 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: 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	0378-0081	0378-0081-01	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 · 12 matching rows.

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

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

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	RLD / RS	Approval date
A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29
A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29
A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29
A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL; HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0081-01	EA - Each	0378-0081	3522891c-c659-4e3d-9668-48d7511d7817	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPTOPRIL	ACTIVE INGREDIENT	9G64RSX1XD	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
CAPTOPRIL	ACTIVE MOIETY	9G64RSX1XD	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.]	6

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CAPTOPRIL AND HYDROCHLOROTHIAZIDE	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	Rising Pharma Holdings, Inc.	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	2023-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074896 application number: ANDA074896

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9G64RSX1XD	CAPTOPRIL	62571-86-2	CAPTOPRIL
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
0378-0081-01	00378008101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0081-01)	100 tablet	1997-12-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Captopril and Hydrochlorothiazide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2020-04-17	HUMAN PRESCRIPTION DRUG LABEL	8