Telmisartan

Product NDC
45865-836
11-digit product format
458650836
Labeler code
45865
Product ID
45865-836_7df0b5b1-1972-3f2a-e053-2a91aa0ad45e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA202130
Marketing category
ANDA
Marketing start
2016-06-25
Marketing end
0000-00-00
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
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-836-60Telmisartan60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-836TELMISARTAN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181227_7df0d592-0010-18a8-e053-2991aa0a867d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSN7df0d592-0010-18a8-e053-2991aa0a867d1
205304telmisartan 40 MG Oral TabletSCD7df0d592-0010-18a8-e053-2991aa0a867d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-836-604586508366060 TABLET in 1 BOTTLE (45865-836-60) 60 tablet2018-06-010000-00-00NoNoCurrent