Telmisartan

Product NDC
70756-314
11-digit product format
707560314
Labeler code
70756
Product ID
70756-314_28abd7a9-b660-4c91-b5f4-b65aa673fdbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA218157
Marketing category
ANDA
Marketing start
2024-10-15
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
A218157-001TELMISARTANTELMISARTAN20MGTABLET / ORALAB2024-10-15
A218157-002TELMISARTANTELMISARTAN40MGTABLET / ORALAB2024-10-15
A218157-003TELMISARTANTELMISARTAN80MGTABLET / ORALAB2024-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218157-001AB
A218157-002AB
A218157-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-152680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-001TELMISARTAN20MGTABLET / ORALAB2024-10-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-002TELMISARTAN40MGTABLET / ORALAB2024-10-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-003TELMISARTAN80MGTABLET / ORALAB2024-10-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218157-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218157-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218157-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218157-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218157-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218157-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218157-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218157-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218157-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218157-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218157-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218157-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218157-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218157-003AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218157-003AB1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218157-003AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan
Listing expiration
2026-12-31

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
3ff464e6-7a36-4544-a06f-7848414f77fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-314-01Telmisartan10 in 1 BLISTER PACKTABLET104
70756-314-30Telmisartan30 in 1 BOTTLETABLET304
70756-314-80Telmisartan8 in 1 CARTONTABLET84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-314-30EA - Each70756-314b725bc6f-4fd4-4b98-af97-29d0c55a228712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-314TELMISARTAN TABLET [LIFESTAR PHARMA LLC]4Current NDC, 3 package rows20241019_3ff464e6-7a36-4544-a06f-7848414f77fc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANLifestar Pharma LLC3ff464e6-7a36-4544-a06f-7848414f77fc2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218157
application number: ANDA218157
ndc (product): 70756-314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
205304telmisartan 40 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
205305telmisartan 80 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
282755telmisartan 20 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4
205304telmisartan 40 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4
205305telmisartan 80 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-314-017075603140110 in 1 BLISTER PACKHistorical
70756-314-307075603143030 TABLET in 1 BOTTLE (70756-314-30) 30 tablet2024-10-15NoNoCurrent
70756-314-80707560314808 BLISTER PACK in 1 CARTON (70756-314-80) / 10 TABLET in 1 BLISTER PACK (70756-314-01) 8 blister pack2024-10-15NoNoCurrent