Micardis

Product NDC
0597-0040
Requested package NDC
0597-0040-37
11-digit product format
005970040
Labeler code
0597
Product ID
0597-0040_333f0ca9-928d-45af-92b9-9ea8a4d02f7d
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
2026-06-30
Substance
TELMISARTAN
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-00400597-0040-37DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020850-001MICARDISTELMISARTAN40MGTABLET / ORALRLD1998-11-10
N020850-002MICARDISTELMISARTAN80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-11-10
N020850-003MICARDISTELMISARTAN20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020850-001MICARDIS40MGTABLET / ORALRLD1998-11-10caaa826d4ba7…
2026-08-18 06:07:402026-07N020850-002MICARDIS80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-11-10caaa826d4ba7…
2026-08-18 06:07:402026-07N020850-003MICARDIS20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020850-002MICARDIS80MGTABLET / ORALRLD1998-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020850-003MICARDIS20MGTABLET / ORALRLD2000-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020850-002MICARDIS80MGTABLET / ORALRLD1998-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020850-003MICARDIS20MGTABLET / ORALRLD2000-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020850-002MICARDIS80MGTABLET / ORALRLD1998-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-002MICARDIS80MGTABLET / ORALABRLD1998-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-002MICARDIS80MGTABLET / ORALABRLD, RS1998-11-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-003MICARDIS20MGTABLET / ORALABRLD2000-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020850-001MICARDIS40MGTABLET / ORALABRLD1998-11-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020850-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020850-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020850-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020850-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020850-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020850-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020850-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020850-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020850-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020850-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020850-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020850-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020850-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020850-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020850-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020850-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020850-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020850-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020850-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020850-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020850-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020850-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020850-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020850-003AB15c6f7cd8ea54…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020850-00280036792022-10-06U-11762011-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020850-00280036792022-10-06U-11762011-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020850-00280036792022-10-06U-11762011-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020850-00163589862020-01-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020850-00263589862020-01-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020850-00279989532020-06-06U-11772011-09-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020850-00280036792022-10-06U-11762011-09-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020850-00363589862020-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020850-00280036792022-10-06U-11762011-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020850-00280036792022-10-06U-11762011-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020850-00280036792022-10-06U-11762011-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N020850-00280036792022-10-06U-11762011-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020850-00163589862020-01-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020850-00263589862020-01-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020850-00279989532020-06-06U-11772011-09-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020850-00280036792022-10-06U-11762011-09-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020850-00363589862020-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020850-00163589862020-01-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020850-00263589862020-01-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020850-00279989532020-06-06U-11772011-09-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020850-00280036792022-10-06U-11762011-09-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020850-00363589862020-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020850-00163589862020-01-103f01610625f2…
2019-12-14 00:12 UTC2019-12N020850-00263589862020-01-103f01610625f2…
2019-12-14 00:12 UTC2019-12N020850-00279989532020-06-06U-11772011-09-093f01610625f2…
2019-12-14 00:12 UTC2019-12N020850-00280036792022-10-06U-11762011-09-093f01610625f2…
2019-12-14 00:12 UTC2019-12N020850-00363589862020-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09N020850-00163589862020-01-10b00525d2431f…
2019-09-15 20:21 UTC2019-09N020850-00263589862020-01-10b00525d2431f…
2019-09-15 20:21 UTC2019-09N020850-00279989532020-06-06U-11772011-09-09b00525d2431f…
2019-09-15 20:21 UTC2019-09N020850-00280036792022-10-06U-11762011-09-09b00525d2431f…
2019-09-15 20:21 UTC2019-09N020850-00363589862020-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N020850-00163589862020-01-10ea99ee380514…
2019-07-19 19:46 UTC2019-07N020850-00263589862020-01-10ea99ee380514…
2019-07-19 19:46 UTC2019-07N020850-00279989532020-06-06U-11772011-09-09ea99ee380514…
2019-07-19 19:46 UTC2019-07N020850-00280036792022-10-06U-11762011-09-09ea99ee380514…
2019-07-19 19:46 UTC2019-07N020850-00363589862020-01-10ea99ee380514…
2023-01-26 05:58 UTC2023-01N020850-00280036792022-10-06U-11762011-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020850-00280036792022-10-06U-11762011-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020850-00280036792022-10-06U-11762011-09-09f41ea6bd6efb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0040-37Micardis10 in 1 BLISTER PACKTABLET1031
0597-0040-37Micardis3 in 1 CARTONTABLET331

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0040-37EA - Each0597-004064263c11-5d4f-4e96-bd0a-8ac1be152eff12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0040MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 2 package rows20250523_cfb9309f-e0df-4a55-9542-0e869fce05fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284531Micardis 20 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
213431Micardis 40 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
213432Micardis 80 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
282755telmisartan 20 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
205304telmisartan 40 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
205305telmisartan 80 MG Oral TabletPSNcfb9309f-e0df-4a55-9542-0e869fce05fb31
284531telmisartan 20 MG Oral Tablet [Micardis]SBDcfb9309f-e0df-4a55-9542-0e869fce05fb31
213431telmisartan 40 MG Oral Tablet [Micardis]SBDcfb9309f-e0df-4a55-9542-0e869fce05fb31
213432telmisartan 80 MG Oral Tablet [Micardis]SBDcfb9309f-e0df-4a55-9542-0e869fce05fb31
282755telmisartan 20 MG Oral TabletSCDcfb9309f-e0df-4a55-9542-0e869fce05fb31
205304telmisartan 40 MG Oral TabletSCDcfb9309f-e0df-4a55-9542-0e869fce05fb31
205305telmisartan 80 MG Oral TabletSCDcfb9309f-e0df-4a55-9542-0e869fce05fb31
284531Micardis 20 MG Oral TabletSYcfb9309f-e0df-4a55-9542-0e869fce05fb31
213431Micardis 40 MG Oral TabletSYcfb9309f-e0df-4a55-9542-0e869fce05fb31
213432Micardis 80 MG Oral TabletSYcfb9309f-e0df-4a55-9542-0e869fce05fb31
284531Micardis 20 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213431Micardis 40 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213432Micardis 80 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
282755telmisartan 20 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
205304telmisartan 40 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
205305telmisartan 80 MG Oral TabletPSN3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
284531telmisartan 20 MG Oral Tablet [Micardis]SBD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213431telmisartan 40 MG Oral Tablet [Micardis]SBD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213432telmisartan 80 MG Oral Tablet [Micardis]SBD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
282755telmisartan 20 MG Oral TabletSCD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
205304telmisartan 40 MG Oral TabletSCD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
205305telmisartan 80 MG Oral TabletSCD3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
284531Micardis 20 MG Oral TabletSY3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213431Micardis 40 MG Oral TabletSY3bb7bc69-7752-4c16-9c60-e61eb5355a4d5
213432Micardis 80 MG Oral TabletSY3bb7bc69-7752-4c16-9c60-e61eb5355a4d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0040-37005970040373 BLISTER PACK in 1 CARTON (0597-0040-37) / 10 TABLET in 1 BLISTER PACK3 blister pack2000-12-012026-06-30NoNoCurrent