FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Product NDC
16729-366
11-digit product format
167290366
Labeler code
16729
Product ID
16729-366_424dfa88-8ad1-1ec4-e063-6394a90a8dcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA209281
Marketing category
ANDA
Marketing start
2020-09-21
Substance
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
12.5; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD, 0J48LPH2TH
Rxcui403853, 403854, 403855

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-366-10OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED307
16729-366-15OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED907
16729-366-16OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED5007
16729-366-17OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET, FILM COATED10007
16729-366-45OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE10 in 1 BLISTER PACKTABLET, FILM COATED107
16729-366-46OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE100 in 1 CARTONTABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-366-10EA - Each16729-36639fc2de8-f862-4a2d-a12c-bfab23d6c60e12020-09-14
16729-366-15EA - Each16729-3663400d9ab-caf6-4425-9c27-24a6d36b5abb12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-366OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 6 package rows20241006_d858a6de-dda5-4bcd-a255-5723d01d896f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403853olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd858a6de-dda5-4bcd-a255-5723d01d896f7
403854olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd858a6de-dda5-4bcd-a255-5723d01d896f7
403855olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd858a6de-dda5-4bcd-a255-5723d01d896f7
403853hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCDd858a6de-dda5-4bcd-a255-5723d01d896f7
403854hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCDd858a6de-dda5-4bcd-a255-5723d01d896f7
403855hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCDd858a6de-dda5-4bcd-a255-5723d01d896f7
403853HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSYd858a6de-dda5-4bcd-a255-5723d01d896f7
403854HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSYd858a6de-dda5-4bcd-a255-5723d01d896f7
403855HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSYd858a6de-dda5-4bcd-a255-5723d01d896f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-366-101672903661030 in 1 BOTTLEHistorical
16729-366-151672903661590 TABLET, FILM COATED in 1 BOTTLE (16729-366-15) 2020-09-210000-00-00NoNoCurrent
16729-366-1616729036616500 in 1 BOTTLEHistorical
16729-366-17167290366171000 in 1 BOTTLEHistorical
16729-366-451672903664510 in 1 BLISTER PACKHistorical
16729-366-4616729036646100 in 1 CARTONHistorical