FDA.reportPublic FDA data

telmisartan

Product NDC
68788-8718
11-digit product format
687888718
Labeler code
68788
Product ID
68788-8718_8d3a861f-2fe6-4968-84b3-a78731b0c725
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA205150
Marketing category
ANDA
Marketing start
2024-07-22
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
68788-8718-3telmisartan30 in 1 BOTTLETABLET302
68788-8718-6telmisartan60 in 1 BOTTLETABLET602
68788-8718-9telmisartan90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8718-3EA - Each68788-871862b949e8-57dc-406c-876d-720a7fc696a612024-09-09
68788-8718-6EA - Each68788-8718e7722eb4-2336-4c89-983e-975d601d73d412024-09-09
68788-8718-9EA - Each68788-871875caf5ed-27a3-4446-b5b9-33614c9ea4ff12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8718TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240730_dd2b0604-f887-40d9-9109-dafcc9987e4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSNdd2b0604-f887-40d9-9109-dafcc9987e4e2
205305telmisartan 80 MG Oral TabletSCDdd2b0604-f887-40d9-9109-dafcc9987e4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8718-36878887180330 TABLET in 1 BOTTLE (68788-8718-3) 30 tablet2024-07-22NoNoHistorical
68788-8718-66878887180660 TABLET in 1 BOTTLE (68788-8718-6) 60 tablet2024-07-22NoNoHistorical
68788-8718-96878887180990 TABLET in 1 BOTTLE (68788-8718-9) 90 tablet2024-07-22NoNoHistorical