Telmisartan and Hydrochlorothiazide

Product NDC
42291-463
11-digit product format
422910463
Labeler code
42291
Product ID
42291-463_5afb1a80-6024-d7fa-e063-6394a90a7ca2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA202544
Marketing category
ANDA
Marketing start
2024-06-18
Substance
TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength
80; 12.5 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
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
A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;40MGTABLET / ORALAB2019-03-04
A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;80MGTABLET / ORALAB2019-03-04
A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN25MG;80MGTABLET / ORALAB2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202544-001AB
A202544-002AB
A202544-003AB

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 22:38:342026-08A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-0484e616aacf4f…
2026-09-14 22:38:342026-08A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-0484e616aacf4f…
2026-09-14 22:38:342026-08A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-0484e616aacf4f…
2026-08-18 06:07:402026-07A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2019-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2019-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202544-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2019-03-04301d65b070ca…

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 22:38:342026-08A202544-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202544-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202544-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202544-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202544-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202544-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202544-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202544-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202544-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202544-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202544-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202544-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202544-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202544-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202544-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202544-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202544-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202544-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202544-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202544-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202544-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202544-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202544-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202544-001AB1301d65b070ca…

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 and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN80 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
U5SYW473RQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283316Internal RxNorm lookup
283317Internal RxNorm lookup
477130Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b303136-dccd-178b-e063-6394a90a35f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-463-11Telmisartan and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET102
42291-463-30Telmisartan and Hydrochlorothiazide3 in 1 BOXTABLET32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-463-11EA - Each42291-463130906f0-3ac1-4cec-811b-6c273b79412712024-07-12
42291-463-30EA - Each42291-46392fe3cbe-daa7-4312-830f-b5a7da9fb17f12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-463TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [AVKARE]1Current NDC, 2 package rows20240620_1b303136-dccd-178b-e063-6394a90a35f8.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
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202544
application number: ANDA202544
ndc (product): 42291-463
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEGlenmark Pharmaceuticals Inc., USA1e55800d-f77c-4950-a6d7-2055f4c7ea172026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202544
application number: ANDA202544

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283316telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1b303136-dccd-178b-e063-6394a90a35f82
283317telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1b303136-dccd-178b-e063-6394a90a35f82
477130telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN1b303136-dccd-178b-e063-6394a90a35f82
283316hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral TabletSCD1b303136-dccd-178b-e063-6394a90a35f82
283317hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral TabletSCD1b303136-dccd-178b-e063-6394a90a35f82
477130hydrochlorothiazide 25 MG / telmisartan 80 MG Oral TabletSCD1b303136-dccd-178b-e063-6394a90a35f82
283316HCTZ 12.5 MG / telmisartan 40 MG Oral TabletSY1b303136-dccd-178b-e063-6394a90a35f82
283317HCTZ 12.5 MG / telmisartan 80 MG Oral TabletSY1b303136-dccd-178b-e063-6394a90a35f82
477130HCTZ 25 MG / telmisartan 80 MG Oral TabletSY1b303136-dccd-178b-e063-6394a90a35f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-463-114229104631110 in 1 BLISTER PACKHistorical
42291-463-30422910463303 BLISTER PACK in 1 BOX (42291-463-30) / 10 TABLET in 1 BLISTER PACK (42291-463-11) 3 blister pack2024-06-18NoNoCurrent