TELMISARTAN

Product NDC
62135-535
11-digit product format
621350535
Labeler code
62135
Product ID
62135-535_459ee4aa-32df-2119-e063-6294a90a0e7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TELMISARTAN
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA078710
Marketing category
ANDA
Marketing start
2020-11-23
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
Rxcui205304, 205305, 282755

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
62135-535-30TELMISARTAN30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-535-30EA - Each62135-535ab16c5ea-b91b-4441-a2b3-9d7ffdd6ed0f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-535TELMISARTAN TABLET [CHARTWELL RX, LLC.]2Current NDC, 1 package rows20241031_beaaf383-730f-4411-b5e7-15c32b53a338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNbeaaf383-730f-4411-b5e7-15c32b53a3383
205304telmisartan 40 MG Oral TabletPSNbeaaf383-730f-4411-b5e7-15c32b53a3383
205305telmisartan 80 MG Oral TabletPSNbeaaf383-730f-4411-b5e7-15c32b53a3383
282755telmisartan 20 MG Oral TabletSCDbeaaf383-730f-4411-b5e7-15c32b53a3383
205304telmisartan 40 MG Oral TabletSCDbeaaf383-730f-4411-b5e7-15c32b53a3383
205305telmisartan 80 MG Oral TabletSCDbeaaf383-730f-4411-b5e7-15c32b53a3383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-535-306213505353030 TABLET in 1 BOTTLE (62135-535-30) 30 tablet2023-03-08NoNoHistorical