FDA.reportPublic FDA data

Telmisartan

Product NDC
68788-8665
11-digit product format
687888665
Labeler code
68788
Product ID
68788-8665_9530b618-6cbe-4d66-aaca-c1bd704f585d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207882
Marketing category
ANDA
Marketing start
2024-05-13
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
68788-8665-3Telmisartan30 in 1 BOTTLETABLET302
68788-8665-6Telmisartan60 in 1 BOTTLETABLET602
68788-8665-9Telmisartan90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8665-3EA - Each68788-86655150b063-8347-4b10-8282-50ae1239b31612024-07-12
68788-8665-6EA - Each68788-8665c48d295f-11b8-4e5f-94af-25fcb0b7b83412024-07-12
68788-8665-9EA - Each68788-8665106ce74e-2b4f-4fb8-a360-c6ecf6a3e47012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8665TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240531_d45da80a-58c3-4461-adf6-a85531c09eb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205304telmisartan 40 MG Oral TabletPSNd45da80a-58c3-4461-adf6-a85531c09eb82
205304telmisartan 40 MG Oral TabletSCDd45da80a-58c3-4461-adf6-a85531c09eb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8665-36878886650330 TABLET in 1 BOTTLE (68788-8665-3) 30 tablet2024-05-13NoNoHistorical
68788-8665-66878886650660 TABLET in 1 BOTTLE (68788-8665-6) 60 tablet2024-05-13NoNoHistorical
68788-8665-96878886650990 TABLET in 1 BOTTLE (68788-8665-9) 90 tablet2024-05-13NoNoHistorical