telmisartan

Product NDC
68382-471
11-digit product format
683820471
Labeler code
68382
Product ID
68382-471_99f660d2-4407-490e-a79f-6523bece714d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA203325
Marketing category
ANDA
Marketing start
2014-08-27
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
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
68382-471-01telmisartan100 in 1 BOTTLETABLET10010
68382-471-05telmisartan500 in 1 BOTTLETABLET50010
68382-471-06telmisartan30 in 1 BOTTLETABLET3010
68382-471-10telmisartan1000 in 1 BOTTLETABLET100010
68382-471-16telmisartan90 in 1 BOTTLETABLET9010
68382-471-30telmisartan1 in 1 BLISTER PACKTABLET110
68382-471-78telmisartan30 in 1 CARTONTABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-471-30EA - Each68382-4718c628bab-56d7-40a2-a374-b9d437d03b0d12017-04-05
68382-471-78EA - Each68382-471953dd1d5-32c8-4398-b090-6d492994ad6e12014-10-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-471TELMISARTAN TABLET [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 7 package rows20231110_e61c209a-4fc3-4f5c-b526-6412f0b8897c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNe61c209a-4fc3-4f5c-b526-6412f0b8897c10
205304telmisartan 40 MG Oral TabletPSNe61c209a-4fc3-4f5c-b526-6412f0b8897c10
205305telmisartan 80 MG Oral TabletPSNe61c209a-4fc3-4f5c-b526-6412f0b8897c10
282755telmisartan 20 MG Oral TabletSCDe61c209a-4fc3-4f5c-b526-6412f0b8897c10
205304telmisartan 40 MG Oral TabletSCDe61c209a-4fc3-4f5c-b526-6412f0b8897c10
205305telmisartan 80 MG Oral TabletSCDe61c209a-4fc3-4f5c-b526-6412f0b8897c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-471-0168382047101100 TABLET in 1 BOTTLE (68382-471-01) 100 tablet2014-08-270000-00-00NoNoCurrent
68382-471-0568382047105500 TABLET in 1 BOTTLE (68382-471-05) 500 tablet2014-08-270000-00-00NoNoCurrent
68382-471-066838204710630 TABLET in 1 BOTTLE (68382-471-06) 30 tablet2014-08-270000-00-00NoNoCurrent
68382-471-10683820471101000 TABLET in 1 BOTTLE (68382-471-10) 1000 tablet2014-08-270000-00-00NoNoCurrent
68382-471-166838204711690 TABLET in 1 BOTTLE (68382-471-16) 90 tablet2014-08-270000-00-00NoNoCurrent
68382-471-30683820471301 in 1 BLISTER PACKHistorical
68382-471-786838204717830 BLISTER PACK in 1 CARTON (68382-471-78) / 1 TABLET in 1 BLISTER PACK (68382-471-30) 30 blister pack2014-08-270000-00-00NoNoCurrent