FDA.reportPublic FDA data

Application 021162

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;40MGYesNo
002MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;80MGYesNo
003MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL25MG;80MGYesYes

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
N021162-001MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;40MGTABLET / ORALABRLD2000-11-17
N021162-002MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;80MGTABLET / ORALABRLD2000-11-17
N021162-003MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN25MG;80MGTABLET / ORALABRLD, RS2004-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021162-001AB
N021162-002AB
N021162-003AB

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 22:54:322026-06N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17a50c72e98297…
2026-08-01 22:54:322026-06N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17a50c72e98297…
2026-08-01 22:54:322026-06N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021162-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021162-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021162-003AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Micardis HCTTELMISARTAN AND HYDROCHLOROTHIAZIDEBoehringer Ingelheim Pharmaceuticals, Inc.b078dae2-664d-4144-847a-3b9d9b5574022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021162
application number: NDA021162
ndc (product): 0597-0044
ndc (product): 0597-0043
ndc (product): 0597-0042

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72985SUPPL2022-12-21
72976SUPPL2022-12-21
64355SUPPL2020-08-21
64340SUPPL2020-08-21
52299SUPPL2018-02-02
52261SUPPL2018-02-02
36249SUPPL2016-01-25
26946SUPPL2016-01-14
36250SUPPL2014-12-16
26947SUPPL2014-12-15
14538SUPPL2012-11-07
4511SUPPL2012-10-26
14537SUPPL2012-01-23
14535SUPPL2012-01-23
4510SUPPL2012-01-23
4509SUPPL2012-01-23
23630ORIG2011-12-22
36248SUPPL2011-05-27
14536SUPPL2011-05-27
26945SUPPL2011-05-06
26944SUPPL2011-05-06
26943SUPPL2009-11-25
4508SUPPL2009-11-25
36247SUPPL2009-09-17
14534SUPPL2009-09-17
4507SUPPL2007-03-06
36246SUPPL2005-09-08
26942SUPPL2005-09-08
26941SUPPL2004-04-29
41996ORIG2004-03-11
36245ORIG2000-11-17
26940ORIG2000-11-17