FDA.reportPublic FDA data

Telmisartan

Product NDC
70518-2572
11-digit product format
705182572
Labeler code
70518
Product ID
70518-2572_4a6824b0-52cc-66ef-e063-6394a90a503f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090032
Marketing category
ANDA
Marketing start
2020-02-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2572-02023-03-10C16284748780-1f386c649-bf23-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
70518-2572-02023-01-30C16284748780-1f386c649-bf23-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2572-0Telmisartan3 in 1 CARTONTABLET37
70518-2572-0Telmisartan10 in 1 BLISTER PACKTABLET107
70518-2572-1Telmisartan30 in 1 BOTTLETABLET307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN91215664-6e19-4e04-9ae7-ab56647994267
205305telmisartan 80 MG Oral TabletSCD91215664-6e19-4e04-9ae7-ab56647994267

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2572-0705182572003 BLISTER PACK in 1 CARTON (70518-2572-0) > 10 TABLET in 1 BLISTER PACK3 blister pack2020-02-100000-00-00NoNoCurrent
70518-2572-17051825720130 TABLET in 1 BOTTLE (70518-2572-1) 30 tablet2025-06-24NoNoCurrent