FDA.reportPublic FDA data

Telmisartan and Amlodipine

Product NDC
0378-1075
11-digit product format
003781075
Labeler code
0378
Product ID
0378-1075_c4f4323d-671d-478b-b088-008530932cee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and amlodipine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202516
Marketing category
ANDA
Marketing start
2014-09-19
Substance
AMLODIPINE BESYLATE; TELMISARTAN
Active strength
5; 40 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Telmisartan and Amlodipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
TELMISARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU5SYW473RQ, 864V2Q084H
Rxcui876514, 876519, 876524, 876529

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-1075-93Telmisartan and Amlodipine30 in 1 BOTTLE, PLASTICTABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1075-93EA - Each0378-107584fbf615-16db-472f-b6a1-f5754591d79a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
AMLODIPINEACTIVE MOIETY1J444QC288TELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ATELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1075TELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20240711_ca60a4d5-ace7-4889-94ee-e2265fd63811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876514telmisartan 40 MG / amLODIPine 10 MG Oral TabletPSNca60a4d5-ace7-4889-94ee-e2265fd638119
876524telmisartan 40 MG / amLODIPine 5 MG Oral TabletPSNca60a4d5-ace7-4889-94ee-e2265fd638119
876519telmisartan 80 MG / amLODIPine 10 MG Oral TabletPSNca60a4d5-ace7-4889-94ee-e2265fd638119
876529telmisartan 80 MG / amLODIPine 5 MG Oral TabletPSNca60a4d5-ace7-4889-94ee-e2265fd638119
876514amlodipine 10 MG / telmisartan 40 MG Oral TabletSCDca60a4d5-ace7-4889-94ee-e2265fd638119
876519amlodipine 10 MG / telmisartan 80 MG Oral TabletSCDca60a4d5-ace7-4889-94ee-e2265fd638119
876524amlodipine 5 MG / telmisartan 40 MG Oral TabletSCDca60a4d5-ace7-4889-94ee-e2265fd638119
876529amlodipine 5 MG / telmisartan 80 MG Oral TabletSCDca60a4d5-ace7-4889-94ee-e2265fd638119
876514amlodipine (as amlodipine besylate) 10 MG / telmisartan 40 MG Oral TabletSYca60a4d5-ace7-4889-94ee-e2265fd638119
876519amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral TabletSYca60a4d5-ace7-4889-94ee-e2265fd638119
876524amlodipine (as amlodipine besylate) 5 MG / telmisartan 40 MG Oral TabletSYca60a4d5-ace7-4889-94ee-e2265fd638119
876529amlodipine (as amlodipine besylate) 5 MG / telmisartan 80 MG Oral TabletSYca60a4d5-ace7-4889-94ee-e2265fd638119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1075-930037810759330 TABLET in 1 BOTTLE, PLASTIC (0378-1075-93) 30 tablet2014-09-190000-00-00NoNoCurrent