TELMISARTAN AND HYDROCHLORTHIAZIDE TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-10-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:51:24

Label at a glance#

ProductTelmisartan and Hydrochlorothiazide
Active ingredientTELMISARTAN, HYDROCHLOROTHIAZIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1123-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
Telmisartan HCTZ Tablet

NDC 70771-1124-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
Telmisartan HCTZ Tablet

NDC 70771-1125-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
Telmisartan HCTZ Tablet

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;40MGTABLET / ORALAB2017-08-15
A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;80MGTABLET / ORALAB2017-08-15
A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN25MG;80MGTABLET / ORALAB2017-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204221-001AB
A204221-002AB
A204221-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15c2088c7a36db…
2026-10-15 13:18:302026-09A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15c2088c7a36db…
2026-10-15 13:18:302026-09A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15c2088c7a36db…
2026-09-14 22:38:342026-08A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-1584e616aacf4f…
2026-09-14 22:38:342026-08A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-1584e616aacf4f…
2026-09-14 22:38:342026-08A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-1584e616aacf4f…
2026-08-18 06:07:402026-07A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-1579d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A204221-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204221-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204221-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A204221-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204221-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204221-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A204221-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204221-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204221-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204221-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204221-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204221-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204221-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204221-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204221-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204221-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204221-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204221-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204221-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204221-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204221-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204221-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204221-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204221-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204221-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-001AB179d66fd596c7…

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
5f887b90-4855-457e-b8da-336dcc16c9bbcbcd600a-4499-4d54-9b50-171a51e8966f2024-12-04Exact identifier
spl set id: cbcd600a-4499-4d54-9b50-171a51e8966f

Reported adverse events (FAERS/openFDA)#

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