FDA.reportPublic FDA data

AMLODIPINE and OLMESARTAN medoxomil

Product NDC
33342-190
11-digit product format
333420190
Labeler code
33342
Product ID
33342-190_bd687a21-be18-439a-8e65-103a15b4a8f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE and OLMESARTAN medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206884
Marketing category
ANDA
Marketing start
2016-10-27
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
5; 20 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE and OLMESARTAN medoxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
OLMESARTAN MEDOXOMIL20 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-190-07AMLODIPINE and OLMESARTAN medoxomil30 in 1 BOTTLETABLET, FILM COATED306
33342-190-10AMLODIPINE and OLMESARTAN medoxomil90 in 1 BOTTLETABLET, FILM COATED906
33342-190-12AMLODIPINE and OLMESARTAN medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED106
33342-190-12AMLODIPINE and OLMESARTAN medoxomil10 in 1 CARTONTABLET, FILM COATED106
33342-190-44AMLODIPINE and OLMESARTAN medoxomil1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-190-07EA - Each33342-19061af3fda-21a3-4632-a99b-e7516177b33312016-11-08
33342-190-10EA - Each33342-190b8197590-6e7b-41f9-9b46-86f86b51e17412016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-190AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 5 package rows20221214_c86a3c45-c906-46c9-9f7b-6c3d89bbe48f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSNc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSNc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSNc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSNc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCDc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCDc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCDc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCDc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSYc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSYc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSYc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSYc86a3c45-c906-46c9-9f7b-6c3d89bbe48f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-190-073334201900730 TABLET, FILM COATED in 1 BOTTLE (33342-190-07) 2016-10-270000-00-00NoNoCurrent
33342-190-103334201901090 TABLET, FILM COATED in 1 BOTTLE (33342-190-10) 2016-10-270000-00-00NoNoCurrent
33342-190-123334201901210 BLISTER PACK in 1 CARTON (33342-190-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2016-10-270000-00-00NoNoCurrent
33342-190-44333420190441000 TABLET, FILM COATED in 1 BOTTLE (33342-190-44) 2016-10-270000-00-00NoNoCurrent