CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product NDC: 16571-829
Requested package NDC: 16571-829-09
11-digit product format: 165710829
Labeler code: 16571
Product ID: 16571-829_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA074896
Marketing category: ANDA
Marketing start: 2023-02-14
Substance: CAPTOPRIL; HYDROCHLOROTHIAZIDE
Active strength: 50; 15 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 · 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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074896-001	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;15MG	TABLET / ORAL		1997-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074896-002	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	RS	1997-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074896-003	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;25MG	TABLET / ORAL		1997-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074896-004	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	50MG;15MG	TABLET / ORAL	RS	1997-12-29	`caaa826d4ba7…`
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…`

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: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPTOPRIL	50 mg/1
HYDROCHLOROTHIAZIDE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9G64RSX1XD	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
197436	Internal RxNorm lookup
197437	Internal RxNorm lookup
197438	Internal RxNorm lookup
197439	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
0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	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
d5efca61-58ec-b4d0-77f8-f2b1fb112156	Product name	4	20240223
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
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	Strength	SPL version
16571-829-09	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-829-09	EA - Each	16571-829	dcbd88ed-5eff-49f6-b9b0-d805ffc75874	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-829	CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMA HOLDINGS, INC.]	1	Current NDC, 1 package rows	20230225_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e.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 · 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 ndc (package): 16571-829-09 ndc (product): 16571-829 ndc11 (package): 16571082909

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197436	captopril 25 MG / hydroCHLOROthiazide 15 MG Oral Tablet	PSN	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197437	captopril 25 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197438	captopril 50 MG / hydroCHLOROthiazide 15 MG Oral Tablet	PSN	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197439	captopril 50 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197436	captopril 25 MG / hydrochlorothiazide 15 MG Oral Tablet	SCD	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197437	captopril 25 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197438	captopril 50 MG / hydrochlorothiazide 15 MG Oral Tablet	SCD	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197439	captopril 50 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197436	captopril 25 MG / HCTZ 15 MG Oral Tablet	SY	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197437	captopril 25 MG / HCTZ 25 MG Oral Tablet	SY	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197438	captopril 50 MG / HCTZ 15 MG Oral Tablet	SY	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1
197439	captopril 50 MG / HCTZ 25 MG Oral Tablet	SY	0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16571-829-09	16571082909	90 TABLET in 1 BOTTLE (16571-829-09)	90 tablet	2023-02-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CAPTOPRIL - Rising Pharma Holdings, Inc. \| APPCO PHARMA LLC	Rising Pharma Holdings, Inc. \| APPCO PHARMA LLC	2023-02-21	Human Prescription Drug Label	1