FDA.reportPublic FDA data

telmisartan

Product NDC
65841-806
11-digit product format
658410806
Labeler code
65841
Product ID
65841-806_9e0aa50a-1fac-4086-b7b6-811cec3f524b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203325
Marketing category
ANDA
Marketing start
2014-08-27
Substance
TELMISARTAN
Active strength
80 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
telmisartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205304, 205305, 282755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-806-01telmisartan100 in 1 BOTTLETABLET1008
65841-806-05telmisartan500 in 1 BOTTLETABLET5008
65841-806-06telmisartan30 in 1 BOTTLETABLET308
65841-806-10telmisartan1000 in 1 BOTTLETABLET10008
65841-806-16telmisartan90 in 1 BOTTLETABLET908
65841-806-30telmisartan1 in 1 BLISTER PACKTABLET18
65841-806-78telmisartan30 in 1 CARTONTABLET308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1
SORBITOLINACTIVE INGREDIENT506T60A25RTELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-806TELMISARTAN TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20240815_2e3cc412-fa44-4304-aabc-d6e412f81fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN2e3cc412-fa44-4304-aabc-d6e412f81fbf8
205304telmisartan 40 MG Oral TabletPSN2e3cc412-fa44-4304-aabc-d6e412f81fbf8
205305telmisartan 80 MG Oral TabletPSN2e3cc412-fa44-4304-aabc-d6e412f81fbf8
282755telmisartan 20 MG Oral TabletSCD2e3cc412-fa44-4304-aabc-d6e412f81fbf8
205304telmisartan 40 MG Oral TabletSCD2e3cc412-fa44-4304-aabc-d6e412f81fbf8
205305telmisartan 80 MG Oral TabletSCD2e3cc412-fa44-4304-aabc-d6e412f81fbf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-806-0165841080601100 TABLET in 1 BOTTLE (65841-806-01) 100 tablet2014-08-270000-00-00NoNoCurrent
65841-806-0565841080605500 TABLET in 1 BOTTLE (65841-806-05) 500 tablet2014-08-270000-00-00NoNoCurrent
65841-806-066584108060630 TABLET in 1 BOTTLE (65841-806-06) 30 tablet2014-08-270000-00-00NoNoCurrent
65841-806-10658410806101000 TABLET in 1 BOTTLE (65841-806-10) 1000 tablet2014-08-270000-00-00NoNoCurrent
65841-806-166584108061690 TABLET in 1 BOTTLE (65841-806-16) 90 tablet2014-08-270000-00-00NoNoCurrent
65841-806-30658410806301 in 1 BLISTER PACKHistorical
65841-806-786584108067830 BLISTER PACK in 1 CARTON (65841-806-78) / 1 TABLET in 1 BLISTER PACK (65841-806-30) 30 blister pack2014-08-270000-00-00NoNoCurrent