Fosinopril Sodium and Hydrochlorothiazide

Product NDC
69097-973
11-digit product format
690970973
Labeler code
69097
Product ID
69097-973_25e66ad5-947a-4262-a996-a9695601d301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosinopril Sodium and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
CIPLA USA INC.
Application
ANDA090228
Marketing category
ANDA
Marketing start
2020-07-24
Substance
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength
20; 12.5 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09
A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090228-001AB
A090228-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090228-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090228-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090228-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090228-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090228-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090228-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090228-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090228-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090228-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090228-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090228-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090228-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090228-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090228-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090228-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090228-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090228-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090228-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090228-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090228-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090228-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090228-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090228-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090228-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090228-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090228-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090228-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090228-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090228-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090228-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090228-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090228-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090228-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090228-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090228-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090228-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090228-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090228-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090228-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090228-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090228-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090228-002AB174a2ff9319b5…

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
Fosinopril Sodium and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSINOPRIL SODIUM20 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NW2RTH6T2NInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857166Internal RxNorm lookup
857174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e1ed7da-029e-48d6-a5e4-fc7ac11192fbAvailable 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
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
90aa3f6a-97f0-be7e-d25b-b26d56ae287eProduct name320201015
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
69097-973-07Fosinopril Sodium and Hydrochlorothiazide100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-973-07EA - Each69097-973a94f0546-71cd-469d-abc5-2a529137be4112020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-973FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CIPLA USA INC.]2Current NDC, Legacy NDC, 1 package rows20201106_4e1ed7da-029e-48d6-a5e4-fc7ac11192fb.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
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDECIPLA USA INC.4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2020-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090228
application number: ANDA090228
ndc (product): 69097-973

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857166fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857174fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857166fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857174fosinopril sodium 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857166FNP Sodium 10 MG / HCTZ 12.5 MG Oral TabletSY4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857174FNP Sodium 20 MG / HCTZ 12.5 MG Oral TabletSY4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857166fosinopril sodium 10 MG / HCTZ 12.5 MG Oral TabletSY4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2
857174fosinopril sodium 20 MG / HCTZ 12.5 MG Oral TabletSY4e1ed7da-029e-48d6-a5e4-fc7ac11192fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-973-0769097097307100 TABLET in 1 BOTTLE (69097-973-07) 100 tablet2020-07-240000-00-00NoNoCurrent