FDA.reportPublic FDA data

telmisartan

Product NDC
67877-483
11-digit product format
678770483
Labeler code
67877
Product ID
67877-483_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
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
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
67877-483-05telmisartan500 in 1 BOTTLETABLET50010
67877-483-30telmisartan30 in 1 BOTTLETABLET3010
67877-483-90telmisartan90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-483-30EA - Each67877-4836bda142d-a1f7-4597-81fa-2a6e3346041312019-11-12
67877-483-84EA - Each67877-483b24b4a22-b768-41bf-83d0-288eaba8b25c12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-483TELMISARTAN 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
205304telmisartan 40 MG Oral TabletPSN44e810d4-cf04-41d3-bdf8-0681210a669f104
205304telmisartan 40 MG Oral TabletSCD44e810d4-cf04-41d3-bdf8-0681210a669f104
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
205304telmisartan 40 MG Oral TabletPSN963e9245-ec7a-4bf6-9fc0-80f54e3657f03
205304telmisartan 40 MG Oral TabletSCD963e9245-ec7a-4bf6-9fc0-80f54e3657f03
205304telmisartan 40 MG Oral TabletPSN36bd9eb7-12fc-4389-80d8-ca31ae898d862
205304telmisartan 40 MG Oral TabletSCD36bd9eb7-12fc-4389-80d8-ca31ae898d862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-483-0567877048305500 TABLET in 1 BOTTLE (67877-483-05) 500 tablet2019-07-250000-00-00NoNoCurrent
67877-483-306787704833030 TABLET in 1 BOTTLE (67877-483-30) 30 tablet2019-07-250000-00-00NoNoCurrent
67877-483-84678770483843 BLISTER PACK in 1 CARTON (67877-483-84) > 10 TABLET in 1 BLISTER PACK3 blister pack2016-06-120000-00-00NoNoCurrent
67877-483-906787704839090 TABLET in 1 BOTTLE (67877-483-90) 90 tablet2019-07-250000-00-00NoNoCurrent