FDA.reportPublic FDA data

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

Product NDC
16571-830
11-digit product format
165710830
Labeler code
16571
Product ID
16571-830_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; 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
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDECAPTOPRIL; HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29
A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDECAPTOPRIL; HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29
A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDECAPTOPRIL; HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29
A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDECAPTOPRIL; HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074896-001CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL1997-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074896-002CAPTOPRIL AND HYDROCHLOROTHIAZIDE25MG;25MGTABLET / ORALRS1997-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074896-003CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;25MGTABLET / ORAL1997-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074896-004CAPTOPRIL AND HYDROCHLOROTHIAZIDE50MG;15MGTABLET / ORALRS1997-12-29d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPTOPRIL50 mg/1
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9G64RSX1XDInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197436Internal RxNorm lookup
197437Internal RxNorm lookup
197438Internal RxNorm lookup
197439Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
d5efca61-58ec-b4d0-77f8-f2b1fb112156Product name420240223
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-830-09CAPTOPRIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-830-09EA - Each16571-830265611d7-ed09-4c3d-9bbc-da4ad323772a12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-830CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 1 package rows20230225_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPTOPRIL AND HYDROCHLOROTHIAZIDECAPTOPRIL AND HYDROCHLOROTHIAZIDERising Pharma Holdings, Inc.0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e2023-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074896
application number: ANDA074896
ndc (product): 16571-830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197436captopril 25 MG / hydroCHLOROthiazide 15 MG Oral TabletPSN0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197437captopril 25 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197438captopril 50 MG / hydroCHLOROthiazide 15 MG Oral TabletPSN0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197439captopril 50 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197436captopril 25 MG / hydrochlorothiazide 15 MG Oral TabletSCD0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197437captopril 25 MG / hydrochlorothiazide 25 MG Oral TabletSCD0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197438captopril 50 MG / hydrochlorothiazide 15 MG Oral TabletSCD0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197439captopril 50 MG / hydrochlorothiazide 25 MG Oral TabletSCD0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197436captopril 25 MG / HCTZ 15 MG Oral TabletSY0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197437captopril 25 MG / HCTZ 25 MG Oral TabletSY0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197438captopril 50 MG / HCTZ 15 MG Oral TabletSY0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1
197439captopril 50 MG / HCTZ 25 MG Oral TabletSY0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-830-091657108300990 TABLET in 1 BOTTLE (16571-830-09) 90 tablet2023-02-14NoNoCurrent