FDA.reportPublic FDA data

telmisartan

Product NDC
68788-8440
11-digit product format
687888440
Labeler code
68788
Product ID
68788-8440_ba156131-d279-461a-bae0-04d823956311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA205150
Marketing category
ANDA
Marketing start
2023-05-02
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

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
68788-8440-3telmisartan30 in 1 BOTTLETABLET303
68788-8440-6telmisartan60 in 1 BOTTLETABLET603
68788-8440-9telmisartan90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8440-3EA - Each68788-84403479f953-40c7-4b5f-be84-dda3609dfe2012023-06-06
68788-8440-6EA - Each68788-8440bf2faf02-a48c-4e09-a90a-2fdd85ed51e012023-06-06
68788-8440-9EA - Each68788-8440a66bed5c-4c6c-4e92-a0ed-84c0a1f7698612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8440TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240816_963e9245-ec7a-4bf6-9fc0-80f54e3657f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSN963e9245-ec7a-4bf6-9fc0-80f54e3657f03
205304telmisartan 40 MG Oral TabletSCD963e9245-ec7a-4bf6-9fc0-80f54e3657f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8440-36878884400330 TABLET in 1 BOTTLE (68788-8440-3) 30 tablet2023-05-02NoNoHistorical
68788-8440-66878884400660 TABLET in 1 BOTTLE (68788-8440-6) 60 tablet2023-05-02NoNoHistorical
68788-8440-96878884400990 TABLET in 1 BOTTLE (68788-8440-9) 90 tablet2023-05-02NoNoHistorical