Telmisartan

Product NDC
62332-087
11-digit product format
623320087
Labeler code
62332
Product ID
62332-087_eee590f3-5296-4091-a146-e4feedf76565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202130
Marketing category
ANDA
Marketing start
2016-06-25
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
62332-087-10Telmisartan100 in 1 CARTONTABLET10010
62332-087-30Telmisartan30 in 1 BOTTLETABLET3010
62332-087-91Telmisartan1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-087-30EA - Each62332-087595091e0-1332-4783-bfb9-c80317d03eb412016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-087TELMISARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20230221_c62d424c-7630-413c-be2c-3932831c3f1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
205304telmisartan 40 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
205305telmisartan 80 MG Oral TabletPSNc62d424c-7630-413c-be2c-3932831c3f1d10
282755telmisartan 20 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10
205304telmisartan 40 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10
205305telmisartan 80 MG Oral TabletSCDc62d424c-7630-413c-be2c-3932831c3f1d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-087-1062332008710100 TABLET in 1 CARTON (62332-087-10) 100 tablet2016-06-250000-00-00NoNoCurrent
62332-087-306233200873030 TABLET in 1 BOTTLE (62332-087-30) 30 tablet2016-06-250000-00-00NoNoCurrent
62332-087-91623320087911000 TABLET in 1 BOTTLE (62332-087-91) 1000 tablet2016-06-250000-00-00NoNoCurrent