FDA.reportPublic FDA data

Telmisartan

Product NDC
68462-200
11-digit product format
684620200
Labeler code
68462
Product ID
68462-200_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090032
Marketing category
ANDA
Marketing start
2014-07-07
Substance
TELMISARTAN
Active strength
40 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
TELMISARTAN40 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
68462-200-01Telmisartan100 in 1 BOTTLETABLET10012
68462-200-13Telmisartan3 in 1 CARTONTABLET312
68462-200-13Telmisartan10 in 1 BLISTER PACKTABLET1012
68462-200-30Telmisartan30 in 1 BOTTLETABLET3012
68462-200-82Telmisartan10 in 1 BLISTER PACKTABLET1012
68462-200-82Telmisartan5 in 1 CARTONTABLET512
68462-200-90Telmisartan90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-200-13EA - Each68462-2006652b4b1-03a2-4202-9eaa-dd48369d553812014-08-01
68462-200-30EA - Each68462-20044365b3d-6aa9-4d43-ae3b-7379472dfd2512021-04-08
68462-200-90EA - Each68462-200505cf5c9-3e04-48a7-8fa3-b941b896530c12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-200TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 7 package rows20240315_c6eb489d-2946-4c14-839f-d4af761ead31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282755telmisartan 20 MG Oral TabletPSNc6eb489d-2946-4c14-839f-d4af761ead3112
205304telmisartan 40 MG Oral TabletPSNc6eb489d-2946-4c14-839f-d4af761ead3112
205305telmisartan 80 MG Oral TabletPSNc6eb489d-2946-4c14-839f-d4af761ead3112
282755telmisartan 20 MG Oral TabletSCDc6eb489d-2946-4c14-839f-d4af761ead3112
205304telmisartan 40 MG Oral TabletSCDc6eb489d-2946-4c14-839f-d4af761ead3112
205305telmisartan 80 MG Oral TabletSCDc6eb489d-2946-4c14-839f-d4af761ead3112
205304telmisartan 40 MG Oral TabletPSNbf8e95fa-d181-4b46-8609-497e14a73dc11
205304telmisartan 40 MG Oral TabletSCDbf8e95fa-d181-4b46-8609-497e14a73dc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-200-0168462020001100 TABLET in 1 BOTTLE (68462-200-01) 100 tablet2014-07-070000-00-00NoNoCurrent
68462-200-13684620200133 BLISTER PACK in 1 CARTON (68462-200-13) / 10 TABLET in 1 BLISTER PACK3 blister pack2014-07-070000-00-00NoNoCurrent
68462-200-306846202003030 TABLET in 1 BOTTLE (68462-200-30) 30 tablet2020-12-140000-00-00NoNoCurrent
68462-200-82684620200825 BLISTER PACK in 1 CARTON (68462-200-82) / 10 TABLET in 1 BLISTER PACK5 blister pack2020-12-140000-00-00NoNoCurrent
68462-200-906846202009090 TABLET in 1 BOTTLE (68462-200-90) 90 tablet2024-03-07NoNoHistorical