FDA.reportPublic FDA data

Telmisartan

Product NDC
65862-868
11-digit product format
658620868
Labeler code
65862
Product ID
65862-868_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206511
Marketing category
ANDA
Marketing start
2015-09-03
Substance
TELMISARTAN
Active strength
40 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
TELMISARTAN40 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-868-03Telmisartan3 in 1 CARTONTABLET314
65862-868-10Telmisartan10 in 1 BLISTER PACKTABLET1014
65862-868-30Telmisartan30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-868-03EA - Each65862-868aefcf886-24fe-45cf-b27f-1b15f5e753c112016-06-14
65862-868-10EA - Each65862-868967356e0-4786-4c9a-ba06-96e0bddaa5a712017-03-06
65862-868-30EA - Each65862-8682e2301aa-0183-4300-afbc-b52b79e19e8012021-09-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-868TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 3 package rows20240620_fef6532d-438a-435e-a61f-216dd8551339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNfef6532d-438a-435e-a61f-216dd855133914
205304telmisartan 40 MG Oral TabletPSNfef6532d-438a-435e-a61f-216dd855133914
205305telmisartan 80 MG Oral TabletPSNfef6532d-438a-435e-a61f-216dd855133914
282755telmisartan 20 MG Oral TabletSCDfef6532d-438a-435e-a61f-216dd855133914
205304telmisartan 40 MG Oral TabletSCDfef6532d-438a-435e-a61f-216dd855133914
205305telmisartan 80 MG Oral TabletSCDfef6532d-438a-435e-a61f-216dd855133914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-868-03658620868033 BLISTER PACK in 1 CARTON (65862-868-03) / 10 TABLET in 1 BLISTER PACK (65862-868-10) 3 blister pack2015-09-030000-00-00NoNoCurrent
65862-868-106586208681010 in 1 BLISTER PACKHistorical
65862-868-306586208683030 TABLET in 1 BOTTLE (65862-868-30) 30 tablet2019-06-030000-00-00NoNoCurrent