Home NDC 0597-0039-37 Micardis
Product NDC 0597-0039
Requested package NDC 0597-0039-37
11-digit product format 005970039
Labeler code 0597
Product ID 0597-0039_40d4dcd9-5170-4685-bee8-4127d0bac0d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telmisartan
Dosage form TABLET
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA020850
Marketing category NDA
Marketing start 2000-12-01
Marketing end 0000-00-00
Substance TELMISARTAN
Active strength 20 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0597-0039 0597-0039-37 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0597-0039 0597-0039-37 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020850-001 MICARDIS TELMISARTAN 40MG TABLET / ORAL RLD 1998-11-10 N020850-002 MICARDIS TELMISARTAN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-11-10 N020850-003 MICARDIS TELMISARTAN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-04
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 · 126 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 2026-08-18 06:07:40 2026-07 N020850-001 MICARDIS 40MG TABLET / ORAL RLD 1998-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020850-002 MICARDIS 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020850-003 MICARDIS 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-04-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020850-003 MICARDIS 20MG TABLET / ORAL RLD 2000-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020850-003 MICARDIS 20MG TABLET / ORAL RLD 2000-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020850-002 MICARDIS 80MG TABLET / ORAL RLD 1998-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD 1998-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020850-002 MICARDIS 80MG TABLET / ORAL AB RLD, RS 1998-11-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020850-003 MICARDIS 20MG TABLET / ORAL AB RLD 2000-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020850-001 MICARDIS 40MG TABLET / ORAL AB RLD 1998-11-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0039-37 Micardis 10 in 1 BLISTER PACK TABLET 10 31 0597-0039-37 Micardis 3 in 1 CARTON TABLET 3 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TELMISARTAN ACTIVE INGREDIENT U5SYW473RQ MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 21 TELMISARTAN ACTIVE MOIETY U5SYW473RQ MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 21 TELMISARTAN ACTIVE INGREDIENT U5SYW473RQ MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 TELMISARTAN ACTIVE MOIETY U5SYW473RQ MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 POVIDONE INACTIVE INGREDIENT FZ989GH94E MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R MICARDIS (TELMISARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0039 MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 31 Legacy NDC, 2 package rows 20250523_cfb9309f-e0df-4a55-9542-0e869fce05fb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0039-37 00597003937 3 BLISTER PACK in 1 CARTON (0597-0039-37) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2000-12-01 0000-00-00 No No Current