FDA.reportPublic FDA data

telmisartan

Product NDC
68788-8441
11-digit product format
687888441
Labeler code
68788
Product ID
68788-8441_25a84cb9-ebc2-402e-80d1-9170b6500174
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
20 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
TELMISARTAN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui282755

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
68788-8441-3telmisartan30 in 1 BOTTLETABLET303
68788-8441-6telmisartan60 in 1 BOTTLETABLET603
68788-8441-9telmisartan90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8441-3EA - Each68788-84416f0f705b-8a12-40ff-b0f4-991510f8d70d12023-06-06
68788-8441-6EA - Each68788-8441bd47b0b6-5024-4c30-8d8a-a3ef90c86d7612023-06-06
68788-8441-9EA - Each68788-8441fef65355-7c25-4639-b934-81665ccf1c4b12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8441TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240816_f6da5155-9c26-46bb-bc0f-ece4ea21405f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNf6da5155-9c26-46bb-bc0f-ece4ea21405f3
282755telmisartan 20 MG Oral TabletSCDf6da5155-9c26-46bb-bc0f-ece4ea21405f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8441-36878884410330 TABLET in 1 BOTTLE (68788-8441-3) 30 tablet2023-05-02NoNoHistorical
68788-8441-66878884410660 TABLET in 1 BOTTLE (68788-8441-6) 60 tablet2023-05-02NoNoHistorical
68788-8441-96878884410990 TABLET in 1 BOTTLE (68788-8441-9) 90 tablet2023-05-02NoNoHistorical