FDA.reportPublic FDA data

telmisartan

Product NDC
63187-951
11-digit product format
631870951
Labeler code
63187
Product ID
63187-951_8de923a7-5488-4e04-8c58-37a3d5355d00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205150
Marketing category
ANDA
Marketing start
2016-06-12
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
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
TELMISARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205305

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
63187-951-30telmisartan30 in 1 BOTTLETABLET304
63187-951-60telmisartan60 in 1 BOTTLETABLET604
63187-951-90telmisartan90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-951-30EA - Each63187-951c77e08ea-f01c-46f4-b103-61e46b87665b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-951TELMISARTAN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200903_593a53a4-91bc-4e4a-aeff-08fc2efe3dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN593a53a4-91bc-4e4a-aeff-08fc2efe3dd44
205305telmisartan 80 MG Oral TabletSCD593a53a4-91bc-4e4a-aeff-08fc2efe3dd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-951-306318709513030 TABLET in 1 BOTTLE (63187-951-30) 30 tablet2018-01-010000-00-00NoNoCurrent
63187-951-606318709516060 TABLET in 1 BOTTLE (63187-951-60) 60 tablet2018-01-010000-00-00NoNoCurrent
63187-951-906318709519090 TABLET in 1 BOTTLE (63187-951-90) 90 tablet2018-01-010000-00-00NoNoCurrent