FDA.reportPublic FDA data

Telmisartan

Product NDC
43547-285
11-digit product format
435470285
Labeler code
43547
Product ID
43547-285_98f95e17-f88b-4f47-b4bb-5db8f93793f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA207882
Marketing category
ANDA
Marketing start
2017-08-20
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
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
43547-285-03Telmisartan30 in 1 BOTTLETABLET3011
43547-285-09Telmisartan90 in 1 BOTTLETABLET9011
43547-285-50Telmisartan500 in 1 BOTTLETABLET50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-285-03EA - Each43547-285b5214ec9-3437-433f-8e1b-f542558423af12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-285TELMISARTAN TABLET TELMISARTAN TABLET [SOLCO HEALTHCARE US, LLC]9Current NDC, Legacy NDC, 3 package rows20230710_77442f0b-b522-4b19-ac1f-f0ce8576f0be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205305telmisartan 80 MG Oral TabletPSN830741dd-3f3c-4f8e-88c6-dc112166f477102
205305telmisartan 80 MG Oral TabletSCD830741dd-3f3c-4f8e-88c6-dc112166f477102
282755telmisartan 20 MG Oral TabletPSN77442f0b-b522-4b19-ac1f-f0ce8576f0be11
205304telmisartan 40 MG Oral TabletPSN77442f0b-b522-4b19-ac1f-f0ce8576f0be11
205305telmisartan 80 MG Oral TabletPSN77442f0b-b522-4b19-ac1f-f0ce8576f0be11
282755telmisartan 20 MG Oral TabletSCD77442f0b-b522-4b19-ac1f-f0ce8576f0be11
205304telmisartan 40 MG Oral TabletSCD77442f0b-b522-4b19-ac1f-f0ce8576f0be11
205305telmisartan 80 MG Oral TabletSCD77442f0b-b522-4b19-ac1f-f0ce8576f0be11
205305telmisartan 80 MG Oral TabletPSN57da6ef2-2e86-4e4d-90df-73a2a8cf97f67
205305telmisartan 80 MG Oral TabletSCD57da6ef2-2e86-4e4d-90df-73a2a8cf97f67
205305telmisartan 80 MG Oral TabletPSN3f021f06-99df-48d1-e063-6394a90a8d0f1
205305telmisartan 80 MG Oral TabletSCD3f021f06-99df-48d1-e063-6394a90a8d0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-285-034354702850330 TABLET in 1 BOTTLE (43547-285-03) 30 tablet2017-08-200000-00-00NoNoCurrent
43547-285-094354702850990 TABLET in 1 BOTTLE (43547-285-09) 90 tablet2017-08-200000-00-00NoNoCurrent
43547-285-5043547028550500 TABLET in 1 BOTTLE (43547-285-50) 500 tablet2017-08-200000-00-00NoNoCurrent