Telmisartan and Hydrochlorothiazide

Product NDC
70771-1125
Requested package NDC
70771-1125-3
11-digit product format
707711125
Labeler code
70771
Product ID
70771-1125_83bc89db-4caf-4b60-899e-fd45a1474650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA204221
Marketing category
ANDA
Marketing start
2017-10-12
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TELMISARTAN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70771-112570771-1125-3DDiscontinued by firm2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-112570771-1125-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-112570771-1125-3DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2017-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2017-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204221-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2017-08-15301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204221-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204221-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1125-37077111250330 TABLET in 1 BOTTLE (70771-1125-3) 30 tablet2017-10-120000-00-00NoNoCurrent