FDA.reportPublic FDA data

telmisartan and hydrochlorothiazide

Product NDC
70756-317
Requested package NDC
70756-317-31
11-digit product format
707560317
Labeler code
70756
Product ID
70756-317_70efda7e-0c71-4faf-be4e-ef281d7cc297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA218406
Marketing category
ANDA
Marketing start
2025-12-25
Substance
TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength
80; 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
2026-12-31
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
A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;40MGTABLET / ORAL2025-03-03
A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;80MGTABLET / ORAL2025-03-03
A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN25MG;80MGTABLET / ORAL2025-03-03

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 22:38:342026-08A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORAL2025-03-0384e616aacf4f…
2026-08-18 06:07:402026-07A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORAL2025-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORAL2025-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORAL2025-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2025-03-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218406-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORAL2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218406-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218406-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORAL2025-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A218406-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218406-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218406-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218406-003AB1fd3edfee7708…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN80 mg/1
HYDROCHLOROTHIAZIDE25 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
0c1bd0f4-034e-486c-ae46-2855c8c9ebdaAvailable 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
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
70756-317-30telmisartan and hydrochlorothiazide30 in 1 BOTTLETABLET304
70756-317-31telmisartan and hydrochlorothiazide3 in 1 CARTONTABLET34
70756-317-31telmisartan and hydrochlorothiazide10 in 1 BLISTER PACKTABLET104
70756-317-99telmisartan and hydrochlorothiazide10 in 1 BLISTER PACKTABLET104
70756-317-99telmisartan and hydrochlorothiazide10 in 1 CARTONTABLET104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-317-30EA - Each70756-317abc1b6e1-d43a-4e71-af6c-f274df8321ae12025-05-14
70756-317-31EA - Each70756-317f8ebb2fd-026e-4e6c-a1b1-24c613cdfe3b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-317TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LIFESTAR PHARMA LLC]3Current NDC, 5 package rows20250325_0c1bd0f4-034e-486c-ae46-2855c8c9ebda.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
telmisartan and hydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDELifestar Pharma LLC0c1bd0f4-034e-486c-ae46-2855c8c9ebda2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218406
application number: ANDA218406
ndc (package): 70756-317-31
ndc (product): 70756-317
ndc11 (package): 70756031731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283316telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
283317telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
477130telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
283316hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral TabletSCD0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
283317hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral TabletSCD0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
477130hydrochlorothiazide 25 MG / telmisartan 80 MG Oral TabletSCD0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
283316HCTZ 12.5 MG / telmisartan 40 MG Oral TabletSY0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
283317HCTZ 12.5 MG / telmisartan 80 MG Oral TabletSY0c1bd0f4-034e-486c-ae46-2855c8c9ebda4
477130HCTZ 25 MG / telmisartan 80 MG Oral TabletSY0c1bd0f4-034e-486c-ae46-2855c8c9ebda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-317-31707560317313 BLISTER PACK in 1 CARTON (70756-317-31) / 10 TABLET in 1 BLISTER PACK3 blister pack2025-12-25NoNoCurrent