telmisartan and hydrochlorothiazide

Product NDC
0054-0547
11-digit product format
000540547
Labeler code
0054
Product ID
0054-0547_426556da-fe30-4161-9845-e1a7dfbeafda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA021162
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-02-28
Marketing end
2022-11-30
Substance
TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength
80 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0547DDiscontinued by firm2026-08-03
excluded packagepackage0054-05470054-0547-18DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 10 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0054-0547DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-05470054-0547-18DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0054-0547DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-05470054-0547-18DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0054-0547DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-05470054-0547-18DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0054-0547DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-05470054-0547-18DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0054-0547DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-05470054-0547-18DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-002MICARDIS HCT12.5MG;80MGTABLET / ORALABRLD2000-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-003MICARDIS HCT25MG;80MGTABLET / ORALABRLD, RS2004-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021162-001MICARDIS HCT12.5MG;40MGTABLET / ORALABRLD2000-11-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021162-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021162-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021162-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021162-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021162-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021162-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021162-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021162-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021162-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021162-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021162-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021162-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021162-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021162-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021162-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021162-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021162-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021162-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021162-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021162-001AB18072bd15b7f6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021162-00163589862020-01-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021162-00263589862020-01-1074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021162-00163589862020-01-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021162-00263589862020-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021162-00163589862020-01-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021162-00263589862020-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021162-00163589862020-01-103f01610625f2…
2019-12-14 00:12 UTC2019-12N021162-00263589862020-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09N021162-00163589862020-01-10b00525d2431f…
2019-09-15 20:21 UTC2019-09N021162-00263589862020-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N021162-00163589862020-01-10ea99ee380514…
2019-07-19 19:46 UTC2019-07N021162-00263589862020-01-10ea99ee380514…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0547-18EA - Each0054-0547d9c8983d-4b75-42cf-b0e4-65dd39e127bb12014-04-03

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0547-18000540547183 BLISTER PACK in 1 CARTON (0054-0547-18) > 10 TABLET in 1 BLISTER PACK3 blister pack2014-02-280000-00-00NoNoCurrent