Home NDC 0054-0545-18 telmisartan and hydrochlorothiazide
Product NDC 0054-0545
Requested package NDC 0054-0545-18
11-digit product format 000540545
Labeler code 0054
Product ID 0054-0545_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 2022-12-31
Substance TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength 40 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 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.
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 2026-08-01 22:54:32 2026-06 N021162-001 MICARDIS HCT 12.5MG;40MG TABLET / ORAL AB RLD 2000-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N021162-002 MICARDIS HCT 12.5MG;80MG TABLET / ORAL AB RLD 2000-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N021162-003 MICARDIS HCT 25MG;80MG TABLET / ORAL AB RLD, RS 2004-04-19 a50c72e98297…
Observed Orange Book normalized TE 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 0054-0545-18 00054054518 3 BLISTER PACK in 1 CARTON (0054-0545-18) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2014-02-28 2022-12-31 No No Current