Telmisartan

Product NDC
65162-293
11-digit product format
651620293
Labeler code
65162
Product ID
65162-293_1a0e1325-40d8-4dde-8655-54f6bd962a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204415
Marketing category
ANDA
Marketing start
2013-05-31
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-293-03Telmisartan30 in 1 BOTTLETABLET309
65162-293-09Telmisartan90 in 1 BOTTLETABLET909
65162-293-11Telmisartan1000 in 1 BOTTLETABLET10009
65162-293-50Telmisartan500 in 1 BOTTLETABLET5009
65162-293-63Telmisartan3 in 1 CARTONTABLET39
65162-293-63Telmisartan10 in 1 BLISTER PACKTABLET109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-293TELMISARTAN TABLET [AMNEAL PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 6 package rows20241031_20a60231-64f0-4751-aa81-6c0e64334179.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN20a60231-64f0-4751-aa81-6c0e643341799
205304telmisartan 40 MG Oral TabletPSN20a60231-64f0-4751-aa81-6c0e643341799
205305telmisartan 80 MG Oral TabletPSN20a60231-64f0-4751-aa81-6c0e643341799
282755telmisartan 20 MG Oral TabletSCD20a60231-64f0-4751-aa81-6c0e643341799
205304telmisartan 40 MG Oral TabletSCD20a60231-64f0-4751-aa81-6c0e643341799
205305telmisartan 80 MG Oral TabletSCD20a60231-64f0-4751-aa81-6c0e643341799

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-293-036516202930330 TABLET in 1 BOTTLE (65162-293-03) 30 tablet2013-05-310000-00-00NoNoCurrent
65162-293-096516202930990 TABLET in 1 BOTTLE (65162-293-09) 90 tablet2013-05-310000-00-00NoNoCurrent
65162-293-11651620293111000 TABLET in 1 BOTTLE (65162-293-11) 1000 tablet2013-05-310000-00-00NoNoCurrent
65162-293-5065162029350500 TABLET in 1 BOTTLE (65162-293-50) 500 tablet2013-05-310000-00-00NoNoCurrent
65162-293-63651620293633 BLISTER PACK in 1 CARTON (65162-293-63) / 10 TABLET in 1 BLISTER PACK3 blister pack2013-05-310000-00-00NoNoCurrent