Telmisartan

Product NDC
62332-089
11-digit product format
623320089
Labeler code
62332
Product ID
62332-089_eee590f3-5296-4091-a146-e4feedf76565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202130
Marketing category
ANDA
Marketing start
2016-06-25
Substance
TELMISARTAN
Active strength
80 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A202130-001TELMISARTANTELMISARTAN20MGTABLET / ORALAB2014-07-07
A202130-002TELMISARTANTELMISARTAN40MGTABLET / ORALAB2014-07-07
A202130-003TELMISARTANTELMISARTAN80MGTABLET / ORALAB2014-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202130-001AB
A202130-002AB
A202130-003AB

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 06:07:402026-07A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-002TELMISARTAN40MGTABLET / ORALAB2014-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-003TELMISARTAN80MGTABLET / ORALAB2014-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202130-001TELMISARTAN20MGTABLET / ORALAB2014-07-071e350fbaab3a…

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 06:07:402026-07A202130-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202130-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202130-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202130-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202130-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202130-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202130-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202130-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202130-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202130-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202130-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202130-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202130-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202130-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202130-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202130-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202130-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202130-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202130-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202130-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202130-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202130-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U5SYW473RQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205304Internal RxNorm lookup
205305Internal RxNorm lookup
282755Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c62d424c-7630-413c-be2c-3932831c3f1dAvailable on FDA.report

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
62332-089-10Telmisartan100 in 1 CARTONTABLET10010
62332-089-30Telmisartan30 in 1 BOTTLETABLET3010
62332-089-91Telmisartan1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-089-30EA - Each62332-08924e2fe35-b737-40ab-9204-ca5bf03ae5e612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-089TELMISARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20230221_c62d424c-7630-413c-be2c-3932831c3f1d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANAlembic Pharmaceuticals Limited4be6575f-ea8d-4cd8-a49d-3d1c93f2621a2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202130
application number: ANDA202130
TelmisartanTELMISARTANAlembic Pharmaceuticals Inc.c62d424c-7630-413c-be2c-3932831c3f1d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202130
application number: ANDA202130
ndc (product): 62332-089

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
205304telmisartan 40 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
205305telmisartan 80 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
282755telmisartan 20 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10
205304telmisartan 40 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10
205305telmisartan 80 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-089-1062332008910100 TABLET in 1 CARTON (62332-089-10) 100 tablet2016-06-250000-00-00NoNoCurrent
62332-089-306233200893030 TABLET in 1 BOTTLE (62332-089-30) 30 tablet2016-06-250000-00-00NoNoCurrent
62332-089-91623320089911000 TABLET in 1 BOTTLE (62332-089-91) 1000 tablet2016-06-250000-00-00NoNoCurrent