FDA.reportPublic FDA data

telmisartan

Product NDC
68071-4937
11-digit product format
680714937
Labeler code
68071
Product ID
68071-4937_bb9f6bdd-026f-5b53-e053-2a95a90ab4ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205150
Marketing category
ANDA
Marketing start
2016-06-12
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-4937-32023-01-30C16284748780-1ba0f9c33-5a03-a910-e053-dadaa90a0b85These 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
68071-4937-32021-02-18C16284748780-1ba0f9c33-5a03-a910-e053-dadaa90a0b85These 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
68071-4937-32021-01-29C16284748780-1ba0f9c33-5a03-a910-e053-dadaa90a0b85These 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
68071-4937-3telmisartan30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4937TELMISARTAN TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20210219_8bdd116a-acc8-2d2b-e053-2a95a90a2b5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN8bdd116a-acc8-2d2b-e053-2a95a90a2b5b2
205305telmisartan 80 MG Oral TabletSCD8bdd116a-acc8-2d2b-e053-2a95a90a2b5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4937-36807149370330 TABLET in 1 BOTTLE (68071-4937-3) 30 tablet2019-06-210000-00-00NoNoCurrent