FDA.reportPublic FDA data

Telmisartan

Product NDC
59746-441
11-digit product format
597460441
Labeler code
59746
Product ID
59746-441_482ba8bc-d601-48d8-9d50-8fa4d2c255fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA204164
Marketing category
ANDA
Marketing start
2016-08-22
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
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
59746-441-12Telmisartan10 in 1 BLISTER PACKTABLET104
59746-441-32Telmisartan3 in 1 CARTONTABLET34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-441-12EA - Each59746-4414262f022-2d93-47c6-bc01-ab58c6c06fc212017-12-14
59746-441-32EA - Each59746-44140ccabf4-fa07-470c-b365-61129504dc8112017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-441TELMISARTAN TABLET [JUBILANT CADISTA PHARMACUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250117_e1a907a7-fad9-a860-8639-4c6136c85734.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNe1a907a7-fad9-a860-8639-4c6136c857344
205304telmisartan 40 MG Oral TabletPSNe1a907a7-fad9-a860-8639-4c6136c857344
205305telmisartan 80 MG Oral TabletPSNe1a907a7-fad9-a860-8639-4c6136c857344
282755telmisartan 20 MG Oral TabletSCDe1a907a7-fad9-a860-8639-4c6136c857344
205304telmisartan 40 MG Oral TabletSCDe1a907a7-fad9-a860-8639-4c6136c857344
205305telmisartan 80 MG Oral TabletSCDe1a907a7-fad9-a860-8639-4c6136c857344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59746-441-125974604411210 in 1 BLISTER PACKHistorical
59746-441-32597460441323 BLISTER PACK in 1 CARTON (59746-441-32) / 10 TABLET in 1 BLISTER PACK (59746-441-12) 3 blister pack2016-08-22NoNoHistorical