FDA.reportPublic FDA data

Telmisartan and Amlodipine

Product NDC
46708-187
11-digit product format
467080187
Labeler code
46708
Product ID
46708-187_f0d9160e-9405-435e-9f36-75c537267221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Amlodipine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA205234
Marketing category
ANDA
Marketing start
2016-11-22
Substance
AMLODIPINE BESYLATE; TELMISARTAN
Active strength
10; 80 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 BESYLATE10 mg/1
TELMISARTAN80 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-187-062023-02-01C16284748780-1f386c649-f4fb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 2009
46708-187-062023-01-30C16284748780-1f386c649-f4fb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-187-06Telmisartan and Amlodipine60 in 1 CARTONTABLET604
46708-187-06Telmisartan and Amlodipine6 in 1 BLISTER PACKTABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-187TELMISARTAN AND AMLODIPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20230202_15b438b4-4874-43f4-a50a-4e6f3e5530ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876514telmisartan 40 MG / amLODIPine 10 MG Oral TabletPSN15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876524telmisartan 40 MG / amLODIPine 5 MG Oral TabletPSN15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876519telmisartan 80 MG / amLODIPine 10 MG Oral TabletPSN15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876529telmisartan 80 MG / amLODIPine 5 MG Oral TabletPSN15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876514amlodipine 10 MG / telmisartan 40 MG Oral TabletSCD15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876519amlodipine 10 MG / telmisartan 80 MG Oral TabletSCD15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876524amlodipine 5 MG / telmisartan 40 MG Oral TabletSCD15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876529amlodipine 5 MG / telmisartan 80 MG Oral TabletSCD15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876514amlodipine (as amlodipine besylate) 10 MG / telmisartan 40 MG Oral TabletSY15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876519amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral TabletSY15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876524amlodipine (as amlodipine besylate) 5 MG / telmisartan 40 MG Oral TabletSY15b438b4-4874-43f4-a50a-4e6f3e5530ac4
876529amlodipine (as amlodipine besylate) 5 MG / telmisartan 80 MG Oral TabletSY15b438b4-4874-43f4-a50a-4e6f3e5530ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-187-064670801870660 BLISTER PACK in 1 CARTON (46708-187-06) / 6 TABLET in 1 BLISTER PACK60 blister pack2016-11-220000-00-00NoNoCurrent