FDA.reportPublic FDA data

Telmisartan

Product NDC
0378-2922
11-digit product format
003782922
Labeler code
0378
Product ID
0378-2922_0bdc0a35-e9b0-41a9-96f8-5b85497298f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202397
Marketing category
ANDA
Marketing start
2014-07-07
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
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
TELMISARTAN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ
Rxcui205304, 205305, 282755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-2922-77Telmisartan90 in 1 BOTTLE, PLASTICTABLET9011
0378-2922-93Telmisartan30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2922-77EA - Each0378-2922c58b1508-1583-4916-adc7-e3261e5a9d2512014-08-01
0378-2922-93EA - Each0378-2922f412990c-9236-4b53-824e-561b65d5945e12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ATELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2922TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240124_c3658bc8-1524-43db-930e-66f9ac01b808.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNc3658bc8-1524-43db-930e-66f9ac01b80811
205304telmisartan 40 MG Oral TabletPSNc3658bc8-1524-43db-930e-66f9ac01b80811
205305telmisartan 80 MG Oral TabletPSNc3658bc8-1524-43db-930e-66f9ac01b80811
282755telmisartan 20 MG Oral TabletSCDc3658bc8-1524-43db-930e-66f9ac01b80811
205304telmisartan 40 MG Oral TabletSCDc3658bc8-1524-43db-930e-66f9ac01b80811
205305telmisartan 80 MG Oral TabletSCDc3658bc8-1524-43db-930e-66f9ac01b80811
205305telmisartan 80 MG Oral TabletPSN509cd338-24db-41d1-a115-9dc9991707174
205305telmisartan 80 MG Oral TabletSCD509cd338-24db-41d1-a115-9dc9991707174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-2922-770037829227790 TABLET in 1 BOTTLE, PLASTIC (0378-2922-77) 90 tablet2014-07-070000-00-00NoNoCurrent
0378-2922-930037829229330 TABLET in 1 BOTTLE, PLASTIC (0378-2922-93) 30 tablet2014-07-070000-00-00NoNoCurrent