Home DailyMed bd7261cc-95ee-4f1f-9619-783cd52eb266 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:34:46 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 22:38:34 2026-08 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Observed Orange Book patent history# 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 ndc (package): 0597-0044-37 ndc11 (package): 00597004437
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.