FDA.reportPublic FDA data

Telmisartan

Product NDC
72241-016
11-digit product format
722410016
Labeler code
72241
Product ID
72241-016_2d61b730-b379-49e1-877a-d14c92ab5b23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA208605
Marketing category
ANDA
Marketing start
2015-02-05
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
72241-016-04Telmisartan90 in 1 BOTTLETABLET904
72241-016-05Telmisartan100 in 1 BOTTLETABLET1004
72241-016-10Telmisartan500 in 1 BOTTLETABLET5004
72241-016-11Telmisartan1000 in 1 BOTTLETABLET10004
72241-016-16Telmisartan30 in 1 CARTONTABLET304
72241-016-16Telmisartan10 in 1 BLISTER PACKTABLET104
72241-016-18Telmisartan30 in 1 CARTONTABLET304
72241-016-18Telmisartan10 in 1 BLISTER PACKTABLET104
72241-016-22Telmisartan30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-016-01EA - Each72241-016734554f7-0f85-4f30-8aaf-92abf78f872112023-03-13
72241-016-22EA - Each72241-01623c0fbf5-33c7-4fda-8ccf-84aff7eafacc12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-016TELMISARTAN TABLET [MODAVAR PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 9 package rows20231004_a075633a-2a2a-4e88-8ede-b49a3920a16c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSNb4ae8694-2af4-4acb-8634-b40c1cb6fb41100
205304telmisartan 40 MG Oral TabletSCDb4ae8694-2af4-4acb-8634-b40c1cb6fb41100
282755telmisartan 20 MG Oral TabletPSNa075633a-2a2a-4e88-8ede-b49a3920a16c4
205304telmisartan 40 MG Oral TabletPSNa075633a-2a2a-4e88-8ede-b49a3920a16c4
205305telmisartan 80 MG Oral TabletPSNa075633a-2a2a-4e88-8ede-b49a3920a16c4
282755telmisartan 20 MG Oral TabletSCDa075633a-2a2a-4e88-8ede-b49a3920a16c4
205304telmisartan 40 MG Oral TabletSCDa075633a-2a2a-4e88-8ede-b49a3920a16c4
205305telmisartan 80 MG Oral TabletSCDa075633a-2a2a-4e88-8ede-b49a3920a16c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-016-047224100160490 TABLET in 1 BOTTLE (72241-016-04) 90 tablet2022-12-22NoNoHistorical
72241-016-0572241001605100 TABLET in 1 BOTTLE (72241-016-05) 100 tablet2022-12-22NoNoHistorical
72241-016-1072241001610500 TABLET in 1 BOTTLE (72241-016-10) 500 tablet2022-12-22NoNoHistorical
72241-016-11722410016111000 TABLET in 1 BOTTLE (72241-016-11) 1000 tablet2022-12-22NoNoHistorical
72241-016-167224100161630 BLISTER PACK in 1 CARTON (72241-016-16) / 10 TABLET in 1 BLISTER PACK30 blister pack2015-02-050000-00-00NoNoCurrent
72241-016-187224100161830 BLISTER PACK in 1 CARTON (72241-016-18) / 10 TABLET in 1 BLISTER PACK30 blister pack2015-02-050000-00-00NoNoCurrent
72241-016-227224100162230 TABLET in 1 BOTTLE (72241-016-22) 30 tablet2022-12-22NoNoHistorical