FDA.reportPublic FDA data

TELMISARTAN

Product NDC
42571-227
11-digit product format
425710227
Labeler code
42571
Product ID
42571-227_f2aa8284-f86c-3425-e053-2995a90a6dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207016
Marketing category
ANDA
Marketing start
2018-01-01
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, 205305, 282755

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
42571-227-05TELMISARTAN500 in 1 BOTTLETABLET50014
42571-227-10TELMISARTAN1000 in 1 BOTTLETABLET100014
42571-227-11TELMISARTAN10 in 1 CARTONTABLET1014
42571-227-30TELMISARTAN30 in 1 BOTTLETABLET3014
42571-227-32TELMISARTAN10 in 1 BLISTER PACKTABLET1014
42571-227-41TELMISARTAN3 in 1 CARTONTABLET314
42571-227-90TELMISARTAN90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-227-30EA - Each42571-227fbb64ae4-d011-4ca0-a948-f504146fcb3212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-227TELMISARTAN (TELMISARTAN) TABLET [MICRO LABS LIMITED]14Current NDC, Legacy NDC, 7 package rows20230121_d7c9bd41-9558-46e1-ab03-82cdf85db3fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNd7c9bd41-9558-46e1-ab03-82cdf85db3fe14
205304telmisartan 40 MG Oral TabletPSNd7c9bd41-9558-46e1-ab03-82cdf85db3fe14
205305telmisartan 80 MG Oral TabletPSNd7c9bd41-9558-46e1-ab03-82cdf85db3fe14
282755telmisartan 20 MG Oral TabletSCDd7c9bd41-9558-46e1-ab03-82cdf85db3fe14
205304telmisartan 40 MG Oral TabletSCDd7c9bd41-9558-46e1-ab03-82cdf85db3fe14
205305telmisartan 80 MG Oral TabletSCDd7c9bd41-9558-46e1-ab03-82cdf85db3fe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-227-0542571022705500 TABLET in 1 BOTTLE (42571-227-05) 500 tablet2018-01-010000-00-00NoNoCurrent
42571-227-10425710227101000 TABLET in 1 BOTTLE (42571-227-10) 1000 tablet2018-01-010000-00-00NoNoCurrent
42571-227-114257102271110 BLISTER PACK in 1 CARTON (42571-227-11) / 10 TABLET in 1 BLISTER PACK (42571-227-32) 10 blister pack2018-01-010000-00-00NoNoCurrent
42571-227-304257102273030 TABLET in 1 BOTTLE (42571-227-30) 30 tablet2018-01-010000-00-00NoNoCurrent
42571-227-324257102273210 in 1 BLISTER PACKHistorical
42571-227-41425710227413 TABLET in 1 CARTON (42571-227-41) 3 tablet2018-01-010000-00-00NoNoCurrent
42571-227-904257102279090 TABLET in 1 BOTTLE (42571-227-90) 90 tablet2018-01-010000-00-00NoNoCurrent