FDA.reportPublic FDA data

telmisartan

Product NDC
67877-482
11-digit product format
678770482
Labeler code
67877
Product ID
67877-482_3176efce-402d-3398-e063-6294a90a2f27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA205150
Marketing category
ANDA
Marketing start
2016-06-12
Substance
TELMISARTAN
Active strength
20 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
TELMISARTAN20 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
67877-482-05telmisartan500 in 1 BOTTLETABLET50010
67877-482-30telmisartan30 in 1 BOTTLETABLET3010
67877-482-90telmisartan90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-482-30EA - Each67877-482c8673c56-b41e-4f1a-a42a-70e47835178712019-11-12
67877-482-84EA - Each67877-48213fbe60a-4fd5-483d-b071-4f04e92dc1a412016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-482TELMISARTAN TABLET [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 3 package rows20250402_29bddc43-2809-4e1f-ae35-2865e15e9bb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN56a72ddf-c2a2-45ce-91b1-1fcfbff52c1011
282755telmisartan 20 MG Oral TabletSCD56a72ddf-c2a2-45ce-91b1-1fcfbff52c1011
282755telmisartan 20 MG Oral TabletPSN29bddc43-2809-4e1f-ae35-2865e15e9bb610
205304telmisartan 40 MG Oral TabletPSN29bddc43-2809-4e1f-ae35-2865e15e9bb610
205305telmisartan 80 MG Oral TabletPSN29bddc43-2809-4e1f-ae35-2865e15e9bb610
282755telmisartan 20 MG Oral TabletSCD29bddc43-2809-4e1f-ae35-2865e15e9bb610
205304telmisartan 40 MG Oral TabletSCD29bddc43-2809-4e1f-ae35-2865e15e9bb610
205305telmisartan 80 MG Oral TabletSCD29bddc43-2809-4e1f-ae35-2865e15e9bb610
282755telmisartan 20 MG Oral TabletPSNf6da5155-9c26-46bb-bc0f-ece4ea21405f3
282755telmisartan 20 MG Oral TabletSCDf6da5155-9c26-46bb-bc0f-ece4ea21405f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-482-0567877048205500 TABLET in 1 BOTTLE (67877-482-05) 500 tablet2019-07-250000-00-00NoNoCurrent
67877-482-306787704823030 TABLET in 1 BOTTLE (67877-482-30) 30 tablet2019-07-250000-00-00NoNoCurrent
67877-482-84678770482843 BLISTER PACK in 1 CARTON (67877-482-84) > 10 TABLET in 1 BLISTER PACK3 blister pack2016-06-120000-00-00NoNoCurrent
67877-482-906787704829090 TABLET in 1 BOTTLE (67877-482-90) 90 tablet2019-07-250000-00-00NoNoCurrent