FDA.reportPublic FDA data

Telmisartan

Product NDC
70756-314
11-digit product format
707560314
Labeler code
70756
Product ID
70756-314_28abd7a9-b660-4c91-b5f4-b65aa673fdbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA218157
Marketing category
ANDA
Marketing start
2024-10-15
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
Rxcui205304, 205305, 282755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-314-01Telmisartan10 in 1 BLISTER PACKTABLET104
70756-314-30Telmisartan30 in 1 BOTTLETABLET304
70756-314-80Telmisartan8 in 1 CARTONTABLET84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-314-30EA - Each70756-314b725bc6f-4fd4-4b98-af97-29d0c55a228712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-314TELMISARTAN TABLET [LIFESTAR PHARMA LLC]4Current NDC, 3 package rows20241019_3ff464e6-7a36-4544-a06f-7848414f77fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
205304telmisartan 40 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
205305telmisartan 80 MG Oral TabletPSN3ff464e6-7a36-4544-a06f-7848414f77fc4
282755telmisartan 20 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4
205304telmisartan 40 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4
205305telmisartan 80 MG Oral TabletSCD3ff464e6-7a36-4544-a06f-7848414f77fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-314-017075603140110 in 1 BLISTER PACKHistorical
70756-314-307075603143030 TABLET in 1 BOTTLE (70756-314-30) 30 tablet2024-10-15NoNoHistorical
70756-314-80707560314808 BLISTER PACK in 1 CARTON (70756-314-80) / 10 TABLET in 1 BLISTER PACK (70756-314-01) 8 blister pack2024-10-15NoNoHistorical