FDA.reportPublic FDA data

Telmisartan

Product NDC
33342-119
11-digit product format
333420119
Labeler code
33342
Product ID
33342-119_94abae59-69ec-482d-b4cf-285d502d82e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203986
Marketing category
ANDA
Marketing start
2025-01-15
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
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
TELMISARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205304, 205305, 282755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-119-07Telmisartan30 in 1 CONTAINERTABLET302
33342-119-10Telmisartan90 in 1 CONTAINERTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-119TELMISARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20250406_671d5a85-4146-43b4-9d7d-ca53268eb2a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN671d5a85-4146-43b4-9d7d-ca53268eb2a62
205304telmisartan 40 MG Oral TabletPSN671d5a85-4146-43b4-9d7d-ca53268eb2a62
205305telmisartan 80 MG Oral TabletPSN671d5a85-4146-43b4-9d7d-ca53268eb2a62
282755telmisartan 20 MG Oral TabletSCD671d5a85-4146-43b4-9d7d-ca53268eb2a62
205304telmisartan 40 MG Oral TabletSCD671d5a85-4146-43b4-9d7d-ca53268eb2a62
205305telmisartan 80 MG Oral TabletSCD671d5a85-4146-43b4-9d7d-ca53268eb2a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-119-073334201190730 TABLET in 1 CONTAINER (33342-119-07) 30 tablet2025-01-15NoNoHistorical
33342-119-103334201191090 TABLET in 1 CONTAINER (33342-119-10) 90 tablet2025-01-15NoNoHistorical