FDA.reportPublic FDA data

Telmisartan

Product NDC
71335-2191
11-digit product format
713352191
Labeler code
71335
Product ID
71335-2191_80eb0c2f-4281-43e4-af6f-366ab65b72f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207882
Marketing category
ANDA
Marketing start
2017-08-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELMISARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205305

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
71335-2191-1Telmisartan90 in 1 BOTTLETABLET90102
71335-2191-2Telmisartan30 in 1 BOTTLETABLET30102
71335-2191-3Telmisartan180 in 1 BOTTLETABLET180102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2191TELMISARTAN TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 3 package rows20231121_830741dd-3f3c-4f8e-88c6-dc112166f477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN830741dd-3f3c-4f8e-88c6-dc112166f477102
205305telmisartan 80 MG Oral TabletSCD830741dd-3f3c-4f8e-88c6-dc112166f477102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2191-17133521910190 TABLET in 1 BOTTLE (71335-2191-1) 90 tablet2022-12-010000-00-00NoNoCurrent
71335-2191-27133521910230 TABLET in 1 BOTTLE (71335-2191-2) 30 tablet2022-12-010000-00-00NoNoCurrent
71335-2191-371335219103180 TABLET in 1 BOTTLE (71335-2191-3) 180 tablet2022-12-01NoNoHistorical