FDA.reportPublic FDA data

Telmisartan

Product NDC
67296-2284
11-digit product format
672962284
Labeler code
67296
Product ID
67296-2284_5743c596-7fcc-a9b5-e063-6294a90a2099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA203986
Marketing category
ANDA
Marketing start
2025-12-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203986-001TELMISARTANTELMISARTAN20MGTABLET / ORALAB2025-01-15
A203986-002TELMISARTANTELMISARTAN40MGTABLET / ORALAB2025-01-15
A203986-003TELMISARTANTELMISARTAN80MGTABLET / ORALAB2025-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203986-001AB
A203986-002AB
A203986-003AB

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
2026-09-14 22:38:342026-08A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-1584e616aacf4f…
2026-08-18 06:07:402026-07A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-15b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-001TELMISARTAN20MGTABLET / ORALAB2025-01-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-002TELMISARTAN40MGTABLET / ORALAB2025-01-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-003TELMISARTAN80MGTABLET / ORALAB2025-01-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203986-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203986-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203986-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203986-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203986-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203986-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203986-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203986-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203986-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203986-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203986-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203986-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203986-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203986-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203986-003AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203986-003AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN20 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5743c58e-deab-ac93-e063-6294a90ac1ebAvailable on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANRedpharm Drug5743c58e-deab-ac93-e063-6294a90ac1eb2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203986
application number: ANDA203986
ndc (product): 67296-2284
TelmisartanTELMISARTANMacleods Pharmaceuticals Limited671d5a85-4146-43b4-9d7d-ca53268eb2a62026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203986
application number: ANDA203986
TelmisartanTELMISARTANNorthStar RxLLC9c22a318-d1f2-4788-9331-66fed71ebf382025-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203986
application number: ANDA203986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2284-96729622840990 TABLET in 1 CONTAINER (67296-2284-9) 90 tablet2025-12-01NoNoCurrent