Home NDC 0054-0546 telmisartan and hydrochlorothiazide
Product NDC 0054-0546
11-digit product format 000540546
Labeler code 0054
Product ID 0054-0546_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 2022-07-31
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# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0054-0546-18 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0054-0546-18 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0054-0546-18 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0054-0546-18 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0054-0546-18 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0054-0546-18 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0054-0546-18 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0054-0546-18 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0054-0546-18 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0054-0546-18 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0054-0546-18 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-0546-18 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# DailyMed Socrata Ingredients# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0546-18 00054054618 3 BLISTER PACK in 1 CARTON (0054-0546-18) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2014-02-28 0000-00-00 No No Current