Home NDC 0054-0547 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 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 0054-0547 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0054-0547 0054-0547-18 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0054-0547 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0054-0547 0054-0547-18 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 0054-0547 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0054-0547 0054-0547-18 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 0054-0547 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0054-0547 0054-0547-18 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 0054-0547 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-0547 0054-0547-18 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021162-001 MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 N021162-002 MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 N021162-003 MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE Boehringer Ingelheim Pharmaceuticals, Inc. b078dae2-664d-4144-847a-3b9d9b557402 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021162 application number: NDA021162
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0547-18 00054054718 3 BLISTER PACK in 1 CARTON (0054-0547-18) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2014-02-28 0000-00-00 No No Current