Telmisartan

Product NDC
0781-5372
11-digit product format
007815372
Labeler code
0781
Product ID
0781-5372_616e4c7d-2752-4514-ba48-d8ba645f6baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA203867
Marketing category
ANDA
Marketing start
2015-02-06
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5372DDiscontinued by firm2026-08-17
excluded packagepackage0781-53720781-5372-06DDiscontinued by firm2026-08-17
excluded packagepackage0781-53720781-5372-64DDiscontinued 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 · 36 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 packagepackage0781-5372-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5372-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5372-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5372-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5372-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5372-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5372-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5372-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5372-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5372-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5372-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5372-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5372-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5372-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5372-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5372-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5372-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5372-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5372-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5372-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5372-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5372-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5372-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5372-64557ba5c1ecfa…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
A203867-001TELMISARTANTELMISARTAN20MGTABLET / ORALAB2014-11-03
A203867-002TELMISARTANTELMISARTAN40MGTABLET / ORALAB2014-11-03
A203867-003TELMISARTANTELMISARTAN80MGTABLET / ORALAB2014-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203867-001AB
A203867-002AB
A203867-003AB

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 06:07:402026-07A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-002TELMISARTAN40MGTABLET / ORALAB2014-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-003TELMISARTAN80MGTABLET / ORALAB2014-11-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203867-001TELMISARTAN20MGTABLET / ORALAB2014-11-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203867-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203867-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203867-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203867-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203867-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203867-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203867-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203867-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203867-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203867-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203867-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203867-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203867-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203867-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203867-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203867-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203867-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203867-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203867-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203867-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203867-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203867-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5372-06EA - Each0781-5372351a6aef-bf40-4326-8a56-dbe29b4fdc6c12015-03-03
0781-5372-64EA - Each0781-537246f3dc87-7ec8-4a8a-998a-9c40f4b6a85e12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [SANDOZ INC]6
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [SANDOZ INC]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTELMISARTAN TABLET [SANDOZ INC]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTELMISARTAN TABLET [SANDOZ INC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTELMISARTAN TABLET [SANDOZ INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [SANDOZ INC]6
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [SANDOZ INC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [SANDOZ INC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [SANDOZ INC]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5372-060078153720610 TABLET in 1 BLISTER PACK (0781-5372-06) 10 tablet2015-02-060000-00-00NoNoCurrent
0781-5372-640078153726430 TABLET in 1 CARTON (0781-5372-64) 30 tablet2015-02-060000-00-00NoNoCurrent