FDA.reportPublic FDA data

Amlodipine and Olmesartan Medoxomil

Product NDC
42291-004
11-digit product format
422910004
Labeler code
42291
Product ID
42291-004_48480a71-5c94-91ab-e063-6294a90a656d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA209010
Marketing category
ANDA
Marketing start
2024-06-18
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
10; 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
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 BESYLATE10 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42291-004-30Amlodipine and Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-004-30EA - Each42291-0041239cc72-0fa6-46dd-91bc-9ca4f32f157012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-004AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [AVKARE]2Current NDC, 1 package rows20240706_1b30c3fe-5c84-0d42-e063-6394a90a81d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSN1b30c3fe-5c84-0d42-e063-6394a90a81d83
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSN1b30c3fe-5c84-0d42-e063-6394a90a81d83
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSN1b30c3fe-5c84-0d42-e063-6394a90a81d83
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSN1b30c3fe-5c84-0d42-e063-6394a90a81d83
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCD1b30c3fe-5c84-0d42-e063-6394a90a81d83
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCD1b30c3fe-5c84-0d42-e063-6394a90a81d83
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCD1b30c3fe-5c84-0d42-e063-6394a90a81d83
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCD1b30c3fe-5c84-0d42-e063-6394a90a81d83
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY1b30c3fe-5c84-0d42-e063-6394a90a81d83
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY1b30c3fe-5c84-0d42-e063-6394a90a81d83
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY1b30c3fe-5c84-0d42-e063-6394a90a81d83
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY1b30c3fe-5c84-0d42-e063-6394a90a81d83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-004-304229100043030 TABLET, FILM COATED in 1 BOTTLE (42291-004-30) 2024-06-18NoNoCurrent