FDA.reportPublic FDA data

amlodipine besylate and olmesartan medoxomil

Product NDC
51407-859
11-digit product format
514070859
Labeler code
51407
Product ID
51407-859_508d4d92-abe0-6182-e063-6394a90a7bcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
NDA022100
Marketing category
NDA
Marketing start
2007-09-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
amlodipine besylate and olmesartan medoxomil
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 6M97XTV3HD
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
51407-859-30amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-859-30EA - Each51407-85988ff021f-ffeb-41c9-a2b3-bc5f273f0e0c12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-859AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20240606_132cca8f-48a2-2516-e063-6394a90a5f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-859-305140708593030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-859-30) 2024-05-13NoNoHistorical