FDA.reportPublic FDA data

Edarbi

Product NDC
60631-040
11-digit product format
606310040
Labeler code
60631
Product ID
60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azilsartan kamedoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA200796
Marketing category
NDA
Marketing start
2013-02-01
Substance
AZILSARTAN KAMEDOXOMIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Edarbi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZILSARTAN KAMEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1091646, 1091650, 1091652, 1091654

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9c73251d-aa60-4cfe-993e-64d90dc1df32Product name120201015
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60631-040-07Edarbi7 in 1 BLISTER PACKTABLET717
60631-040-07Edarbi5 in 1 TRAYTABLET517
60631-040-30Edarbi30 in 1 BOTTLETABLET3017
60631-040-77Edarbi7 in 1 BOTTLETABLET717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60631-040-30EA - Each60631-040c77163b8-b573-4dcc-8b21-4c3fbad697eb12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Azilsartan kamedoxomilACTIVE INGREDIENTWEC6I2K1FCEDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
AzilsartanACTIVE MOIETYF9NUX55P23EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UEDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
fumaric acidINACTIVE INGREDIENT88XHZ13131EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PEDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
magnesium stearateINACTIVE INGREDIENT70097M6I30EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
mannitolINACTIVE INGREDIENT3OWL53L36AEDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5
sodium hydroxideINACTIVE INGREDIENT55X04QC32IEDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [ARBOR PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60631-040EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [AZURITY PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 4 package rows20240131_52b27c75-9f5a-4816-bafd-dace9d7d2063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091646azilsartan medoxomil 40 MG Oral TabletPSN52b27c75-9f5a-4816-bafd-dace9d7d206317
1091652azilsartan medoxomil 80 MG Oral TabletPSN52b27c75-9f5a-4816-bafd-dace9d7d206317
1091650Edarbi 40 MG Oral TabletPSN52b27c75-9f5a-4816-bafd-dace9d7d206317
1091654Edarbi 80 MG Oral TabletPSN52b27c75-9f5a-4816-bafd-dace9d7d206317
1091650azilsartan medoxomil 40 MG Oral Tablet [Edarbi]SBD52b27c75-9f5a-4816-bafd-dace9d7d206317
1091654azilsartan medoxomil 80 MG Oral Tablet [Edarbi]SBD52b27c75-9f5a-4816-bafd-dace9d7d206317
1091646azilsartan medoxomil 40 MG Oral TabletSCD52b27c75-9f5a-4816-bafd-dace9d7d206317
1091652azilsartan medoxomil 80 MG Oral TabletSCD52b27c75-9f5a-4816-bafd-dace9d7d206317
1091646azilsartan medoxomil 40 MG (equivalent to azilsartan kamedoxomil 42.68 MG) Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317
1091652azilsartan medoxomil 80 MG (equivalent to azilsartan kamedoxomil 85.36 MG) Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317
1091650Edarbi 40 MG (azilsartan kamedoxomil 42.68 MG) Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317
1091650Edarbi 40 MG Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317
1091654Edarbi 80 MG (azilsartan kamedoxomil 85.36 MG) Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317
1091654Edarbi 80 MG Oral TabletSY52b27c75-9f5a-4816-bafd-dace9d7d206317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60631-040-07606310040077 in 1 BLISTER PACKHistorical
60631-040-306063100403030 TABLET in 1 BOTTLE (60631-040-30) 30 tablet2013-02-010000-00-00NoNoCurrent
60631-040-77606310040777 TABLET in 1 BOTTLE (60631-040-77) 7 tablet2017-02-01NoNoHistorical