FDA.reportPublic FDA data

Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC
57664-759
Requested package NDC
57664-759-83
11-digit product format
576640759
Labeler code
57664
Product ID
57664-759_5784665f-83c5-4153-937a-61d0f1e2483b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil-hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA021532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-26
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength
40 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
2022-12-31
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 packagepackage57664-75957664-759-83DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-759-83EA - Each57664-7592ed7b805-abb7-4684-8abb-c580dcc9c60712016-11-08
57664-759-99EA - Each57664-7596d34d455-f94b-4252-bead-281655b7a24212016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-759-835766407598330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-759-83) 2016-10-260000-00-00NoNoCurrent