FDA.reportPublic FDA data

Telmisartan

Product NDC
71209-049
11-digit product format
712090049
Labeler code
71209
Product ID
71209-049_a19404d0-fd12-42ab-b469-b8c7d1d5e7eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA208605
Marketing category
ANDA
Marketing start
2015-02-05
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
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
71209-049-01Telmisartan30 in 1 BOTTLETABLET3013
71209-049-04Telmisartan90 in 1 BOTTLETABLET9013
71209-049-05Telmisartan100 in 1 BOTTLETABLET10013
71209-049-10Telmisartan500 in 1 BOTTLETABLET50013
71209-049-11Telmisartan1000 in 1 BOTTLETABLET100013
71209-049-16Telmisartan10 in 1 BLISTER PACKTABLET1013
71209-049-16Telmisartan30 in 1 CARTONTABLET3013
71209-049-18Telmisartan10 in 1 BLISTER PACKTABLET1013
71209-049-18Telmisartan30 in 1 CARTONTABLET3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-049TELMISARTAN TABLET [CADILA PHARMACEUTICALS LIMITED]13Current NDC, Legacy NDC, 9 package rows20231004_353fcb30-2fa7-4ff1-8a18-26f3ec279d00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSN353fcb30-2fa7-4ff1-8a18-26f3ec279d0013
205304telmisartan 40 MG Oral TabletPSN353fcb30-2fa7-4ff1-8a18-26f3ec279d0013
205305telmisartan 80 MG Oral TabletPSN353fcb30-2fa7-4ff1-8a18-26f3ec279d0013
282755telmisartan 20 MG Oral TabletSCD353fcb30-2fa7-4ff1-8a18-26f3ec279d0013
205304telmisartan 40 MG Oral TabletSCD353fcb30-2fa7-4ff1-8a18-26f3ec279d0013
205305telmisartan 80 MG Oral TabletSCD353fcb30-2fa7-4ff1-8a18-26f3ec279d0013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-049-017120900490130 TABLET in 1 BOTTLE (71209-049-01) 30 tablet2022-12-22NoNoHistorical
71209-049-047120900490490 TABLET in 1 BOTTLE (71209-049-04) 90 tablet2022-12-22NoNoHistorical
71209-049-0571209004905100 TABLET in 1 BOTTLE (71209-049-05) 100 tablet2022-12-22NoNoHistorical
71209-049-1071209004910500 TABLET in 1 BOTTLE (71209-049-10) 500 tablet2022-12-22NoNoHistorical
71209-049-11712090049111000 TABLET in 1 BOTTLE (71209-049-11) 1000 tablet2022-12-22NoNoHistorical
71209-049-167120900491630 BLISTER PACK in 1 CARTON (71209-049-16) / 10 TABLET in 1 BLISTER PACK30 blister pack2015-02-050000-00-00NoNoCurrent
71209-049-187120900491830 BLISTER PACK in 1 CARTON (71209-049-18) / 10 TABLET in 1 BLISTER PACK30 blister pack2015-02-050000-00-00NoNoCurrent