FDA.reportPublic FDA data

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product NDC
42571-237
11-digit product format
425710237
Labeler code
42571
Product ID
42571-237_2b531912-67b1-6172-e063-6394a90a178f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207435
Marketing category
ANDA
Marketing start
2018-01-01
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
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
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD, 864V2Q084H
Rxcui730861, 730866, 730869, 730872

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
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
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
42571-237-05AMLODIPINE AND OLMESARTAN MEDOXOMIL500 in 1 BOTTLETABLET5008
42571-237-10AMLODIPINE AND OLMESARTAN MEDOXOMIL1000 in 1 BOTTLETABLET10008
42571-237-30AMLODIPINE AND OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET308
42571-237-90AMLODIPINE AND OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-237-30EA - Each42571-23794083253-7a2b-4ff2-9af6-cc246492117c12018-10-11
42571-237-90EA - Each42571-237f594cd23-b672-44f0-9761-865dd69bc7c012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-237AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 4 package rows20250112_7fcf6a87-7b3e-4cef-8c47-c8a008cfea82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSN7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSN7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSN7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSN7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCD7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCD7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCD7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCD7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY7fcf6a87-7b3e-4cef-8c47-c8a008cfea828
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY7fcf6a87-7b3e-4cef-8c47-c8a008cfea828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-237-0542571023705500 TABLET in 1 BOTTLE (42571-237-05) 500 tablet2018-01-010000-00-00NoNoCurrent
42571-237-10425710237101000 TABLET in 1 BOTTLE (42571-237-10) 1000 tablet2018-01-010000-00-00NoNoCurrent
42571-237-304257102373030 TABLET in 1 BOTTLE (42571-237-30) 30 tablet2018-01-010000-00-00NoNoCurrent
42571-237-904257102379090 TABLET in 1 BOTTLE (42571-237-90) 90 tablet2018-01-010000-00-00NoNoCurrent