FDA.reportPublic FDA data

Telmisartan

Product NDC
71335-2173
11-digit product format
713352173
Labeler code
71335
Product ID
71335-2173_86f00081-2b34-4959-b0bb-e53ea3d797be
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
40 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
TELMISARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205304

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
71335-2173-1Telmisartan30 in 1 BOTTLETABLET30102
71335-2173-2Telmisartan90 in 1 BOTTLETABLET90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2173-1EA - Each71335-2173c960b411-312f-45cd-8eec-13da19ce629012025-01-14
71335-2173-2EA - Each71335-217370f9d8b7-32dd-4dc5-b5e1-1512387c7f7a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2173TELMISARTAN TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 2 package rows20231123_a5ded796-3555-4476-8b37-0cdc88d7594a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSNa5ded796-3555-4476-8b37-0cdc88d7594a102
205304telmisartan 40 MG Oral TabletSCDa5ded796-3555-4476-8b37-0cdc88d7594a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2173-17133521730130 TABLET in 1 BOTTLE (71335-2173-1) 30 tablet2022-10-100000-00-00NoNoCurrent
71335-2173-27133521730290 TABLET in 1 BOTTLE (71335-2173-2) 90 tablet2022-10-100000-00-00NoNoCurrent