Telmisartan

Product NDC
0054-0543
11-digit product format
000540543
Labeler code
0054
Product ID
0054-0543_a80037e5-f0ac-47cf-84f3-a1c5d3a9300d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
NDA020850
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-08
Marketing end
0000-00-00
Substance
TELMISARTAN
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0543DDiscontinued by firm2026-08-17
excluded packagepackage0054-05430054-0543-18DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0543-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0543-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0543-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0543-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0543-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0543-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0543-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0543-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0543-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0543-18ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0543-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0543-18557ba5c1ecfa…9c80585c8c6e…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0543-18EA - Each0054-0543c7f8afbd-4bba-49e5-8ea5-02b6ad78b58a12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [ROXANE LABORATORIES, INC.]2
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [ROXANE LABORATORIES, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0543-18000540543183 BLISTER PACK in 1 CARTON (0054-0543-18) > 10 TABLET in 1 BLISTER PACK3 blister pack2014-01-080000-00-00NoNoCurrent