Telmisartan

Product NDC
70518-3556
11-digit product format
705183556
Labeler code
70518
Product ID
70518-3556_4f93f10a-3e19-8e98-e063-6294a90a0007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207882
Marketing category
ANDA
Marketing start
2022-10-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan
Listing expiration
2027-12-31

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
70518-3556-0Telmisartan30 in 1 BOTTLETABLET307
70518-3556-1Telmisartan30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3556TELMISARTAN TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 2 package rows20240116_57da6ef2-2e86-4e4d-90df-73a2a8cf97f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN57da6ef2-2e86-4e4d-90df-73a2a8cf97f67
205305telmisartan 80 MG Oral TabletSCD57da6ef2-2e86-4e4d-90df-73a2a8cf97f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3556-07051835560030 TABLET in 1 BOTTLE (70518-3556-0) 30 tablet2022-10-170000-00-00NoNoCurrent
70518-3556-17051835560130 TABLET in 1 BOTTLE, PLASTIC (70518-3556-1) 30 tablet2026-04-16NoNoHistorical