FDA.reportPublic FDA data

Benicar HCT

Product NDC
65597-105
Requested package NDC
65597-105-11
11-digit product format
655970105
Labeler code
65597
Product ID
65597-105_95b56527-9a72-45dd-a7a5-378d72a1aba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil-hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo, Inc.
Application
NDA021532
Marketing category
NDA
Marketing start
2003-06-05
Marketing end
2023-09-30
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
13 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65597-10565597-105-11DDiscontinued by firm2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021532-002BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;20MGTABLET / ORALABRLD2003-06-05
N021532-003BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL12.5MG;40MGTABLET / ORALABRLD2003-06-05
N021532-005BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL25MG;40MGTABLET / ORALABRLD, RS2003-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021532-002AB
N021532-003AB
N021532-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021532-002BENICAR HCT12.5MG;20MGTABLET / ORALABRLD2003-06-05a50c72e98297…
2026-08-01 22:54:322026-06N021532-003BENICAR HCT12.5MG;40MGTABLET / ORALABRLD2003-06-05a50c72e98297…
2026-08-01 22:54:322026-06N021532-005BENICAR HCT25MG;40MGTABLET / ORALABRLD, RS2003-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021532-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021532-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021532-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEAvKARE569596a2-98f0-116a-e063-6294a90a3fa12026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021532
application number: NDA021532
Benicar HCTOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.a90915ca-f9d3-4fff-8370-d5dc4cdfc5212026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021532
application number: NDA021532
olmesartan medoxomil-hydrochlorothiazideOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEAvKARE017bc6a3-5b3d-2381-e063-6394a90abece2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021532
application number: NDA021532
Benicar HCTOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.881a1c32-c209-4038-9c5e-c5e46c6e05462023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021532
application number: NDA021532

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
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
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
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-105-30EA - Each65597-105e866d406-14c1-42e3-a5ac-1c9d071abdc312012-07-24
65597-105-90EA - Each65597-105676d3986-c22a-44c4-8aea-df61563773a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
OLMESARTAN MEDOXOMILACTIVE INGREDIENT6M97XTV3HDBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
OLMESARTANACTIVE MOIETY8W1IQP3U10BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]10
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
OLMESARTAN MEDOXOMILACTIVE INGREDIENT6M97XTV3HDBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
OLMESARTANACTIVE MOIETY8W1IQP3U10BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847060Benicar HCT 20 MG / 12.5 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
847055Benicar HCT 40 MG / 12.5 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
847042Benicar HCT 40 MG / 25 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
403853olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
403854olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
403855olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNcd879bd1-38c0-4f72-904b-cf07f31863421
847060hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Benicar HCT]SBDcd879bd1-38c0-4f72-904b-cf07f31863421
847055hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]SBDcd879bd1-38c0-4f72-904b-cf07f31863421
847042hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]SBDcd879bd1-38c0-4f72-904b-cf07f31863421
403853hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCDcd879bd1-38c0-4f72-904b-cf07f31863421
403854hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCDcd879bd1-38c0-4f72-904b-cf07f31863421
403855hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCDcd879bd1-38c0-4f72-904b-cf07f31863421
847060Benicar HCT 20/12.5 Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
847055Benicar HCT 40/12.5 Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
847042Benicar HCT 40/25 Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
403853HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
847060HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Benicar HCT]SYcd879bd1-38c0-4f72-904b-cf07f31863421
403854HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
847055HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]SYcd879bd1-38c0-4f72-904b-cf07f31863421
403855HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSYcd879bd1-38c0-4f72-904b-cf07f31863421
847042HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]SYcd879bd1-38c0-4f72-904b-cf07f31863421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65597-105-11655970105111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-105-11) 2003-07-302023-09-30NoNoCurrent