FDA.reportPublic FDA data

Telmisartan and Amlodipine

Product NDC
68180-196
11-digit product format
681800196
Labeler code
68180
Product ID
68180-196_17a6182b-5050-470e-aa1d-1605fa9e088e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Amlodipine
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA201586
Marketing category
ANDA
Marketing start
2014-01-08
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
Unii864V2Q084H, U5SYW473RQ
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
68180-196-06Telmisartan and Amlodipine30 in 1 BOTTLETABLET3010
68180-196-09Telmisartan and Amlodipine90 in 1 BOTTLETABLET9010
68180-196-12Telmisartan and Amlodipine10 in 1 BLISTER PACKTABLET1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-196-06EA - Each68180-196eaedc0ce-97b6-419f-99fd-1d175590301612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HTELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
TELMISARTANACTIVE INGREDIENTU5SYW473RQTELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
AMLODIPINEACTIVE MOIETY1J444QC288TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
TELMISARTANACTIVE MOIETYU5SYW473RQTELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ATELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ETELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-196TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 3 package rows20231216_a97fefa6-99e6-4eb7-9393-ab2252a2c7d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876514telmisartan 40 MG / amLODIPine 10 MG Oral TabletPSNa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876524telmisartan 40 MG / amLODIPine 5 MG Oral TabletPSNa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876519telmisartan 80 MG / amLODIPine 10 MG Oral TabletPSNa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876529telmisartan 80 MG / amLODIPine 5 MG Oral TabletPSNa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876514amlodipine 10 MG / telmisartan 40 MG Oral TabletSCDa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876519amlodipine 10 MG / telmisartan 80 MG Oral TabletSCDa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876524amlodipine 5 MG / telmisartan 40 MG Oral TabletSCDa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876529amlodipine 5 MG / telmisartan 80 MG Oral TabletSCDa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876514amlodipine (as amlodipine besylate) 10 MG / telmisartan 40 MG Oral TabletSYa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876519amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral TabletSYa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876524amlodipine (as amlodipine besylate) 5 MG / telmisartan 40 MG Oral TabletSYa97fefa6-99e6-4eb7-9393-ab2252a2c7d810
876529amlodipine (as amlodipine besylate) 5 MG / telmisartan 80 MG Oral TabletSYa97fefa6-99e6-4eb7-9393-ab2252a2c7d810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-196-066818001960630 TABLET in 1 BOTTLE (68180-196-06) 30 tablet2014-01-080000-00-00NoNoCurrent
68180-196-096818001960990 TABLET in 1 BOTTLE (68180-196-09) 90 tablet2014-01-080000-00-00NoNoCurrent
68180-196-126818001961210 TABLET in 1 BLISTER PACK (68180-196-12) 10 tablet2014-01-080000-00-00NoNoCurrent