FDA.reportPublic FDA data

Edarbyclor

Product NDC
75929-230
11-digit product format
759290230
Labeler code
75929
Product ID
75929-230_3a99b74e-4a3e-5901-e063-6394a90ad954
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azilsartan kamedoxomil and chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Pharma Packaging Solutions, LLC dba Tjoapack LLC
Application
NDA202331
Marketing category
NDA
Marketing start
2013-02-01
Substance
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Active strength
40; 25 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZILSARTAN KAMEDOXOMIL40 mg/1
CHLORTHALIDONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui1235151, 1235157

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9c73251d-aa60-4cfe-993e-64d90dc1df32Product name120201015
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75929-230-03Edarbyclor30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75929-230EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE) TABLET [PHARMA PACKAGING SOLUTIONS, LLC DBA TJOAPACK LLC]1Current NDC, 1 package rows20240202_10566939-c8b1-18a1-e063-6294a90a7601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235151azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral TabletPSN10566939-c8b1-18a1-e063-6294a90a76012
1235157edarbyclor 40 MG / 25 MG Oral TabletPSN10566939-c8b1-18a1-e063-6294a90a76012
1235157azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral Tablet [Edarbyclor]SBD10566939-c8b1-18a1-e063-6294a90a76012
1235151azilsartan medoxomil 40 MG / chlorthalidone 25 MG Oral TabletSCD10566939-c8b1-18a1-e063-6294a90a76012
1235157Edarbyclor 40/25 (azilsartan medoxomil (azilsartan kamedoxomil 42.68 MG) / chlorthalidone) Oral TabletSY10566939-c8b1-18a1-e063-6294a90a76012
1235157Edarbyclor 40/25 Oral TabletSY10566939-c8b1-18a1-e063-6294a90a76012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75929-230-037592902300330 TABLET in 1 BOTTLE (75929-230-03) 30 tablet2013-02-01NoNoCurrent