FDA.reportPublic FDA data

Telmisartan

Product NDC
50090-5490
11-digit product format
500905490
Labeler code
50090
Product ID
50090-5490_34322a88-3ab2-42a0-a13a-4ad31d5f0509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202397
Marketing category
ANDA
Marketing start
2014-07-07
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5490-02023-02-07C16284748780-1f386c649-a7f0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
50090-5490-02023-01-30C16284748780-1f386c649-a7f0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5490-0Telmisartan90 in 1 BOTTLE, PLASTICTABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5490-0EA - Each50090-54904f216b69-cf82-4ef4-ae76-5922c85d0cc712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5490TELMISARTAN TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20230307_eaed12cd-5bfe-4c98-9afc-025ed86a294f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSNeaed12cd-5bfe-4c98-9afc-025ed86a294f10
205304telmisartan 40 MG Oral TabletSCDeaed12cd-5bfe-4c98-9afc-025ed86a294f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5490-05009054900090 TABLET in 1 BOTTLE, PLASTIC (50090-5490-0) 90 tablet2021-03-160000-00-00NoNoCurrent