FDA.reportPublic FDA data

ATACAND HCT

Product NDC
62559-650
11-digit product format
625590650
Labeler code
62559
Product ID
62559-650_512f014c-894d-43ff-96a6-1ff05bc476e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan Cilexetil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021093
Marketing category
NDA
Marketing start
2018-10-01
Substance
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength
16; 12.5 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
ATACAND HCT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDESARTAN CILEXETIL16 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR85M2X0D68, 0J48LPH2TH
Rxcui578325, 578330, 802749, 805855, 805859, 805863

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
03f056e9-4354-02cc-6010-79c6c9eaac0aProduct name620250521
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
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
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
62559-650-90ATACAND HCT90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-650-90EA - Each62559-650f4e5e8a2-c04b-4c43-9b04-87339a8e9d4412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-650ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20200508_d91152c4-66ba-466f-b4f9-0da628d42b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805863Atacand HCT 16 MG / 12.5 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
805859Atacand HCT 32 MG / 12.5 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
805855Atacand HCT 32 MG / 25 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
578325candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
578330candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
802749candesartan cilexetil 32 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd91152c4-66ba-466f-b4f9-0da628d42b1d4
805863candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Atacand HCT]SBDd91152c4-66ba-466f-b4f9-0da628d42b1d4
805859candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Atacand HCT]SBDd91152c4-66ba-466f-b4f9-0da628d42b1d4
805855candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral Tablet [Atacand HCT]SBDd91152c4-66ba-466f-b4f9-0da628d42b1d4
578325candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDd91152c4-66ba-466f-b4f9-0da628d42b1d4
578330candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral TabletSCDd91152c4-66ba-466f-b4f9-0da628d42b1d4
802749candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral TabletSCDd91152c4-66ba-466f-b4f9-0da628d42b1d4
805863Atacand HCT 16/12.5 Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
805859Atacand HCT 32/12.5 Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
805855Atacand HCT 32/25 Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
578325candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
805863candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral Tablet [Atacand HCT]SYd91152c4-66ba-466f-b4f9-0da628d42b1d4
578330candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
805859candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral Tablet [Atacand HCT]SYd91152c4-66ba-466f-b4f9-0da628d42b1d4
802749candesartan cilexetil 32 MG / HCTZ 25 MG Oral TabletSYd91152c4-66ba-466f-b4f9-0da628d42b1d4
805855candesartan cilexetil 32 MG / HCTZ 25 MG Oral Tablet [Atacand HCT]SYd91152c4-66ba-466f-b4f9-0da628d42b1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-650-906255906509090 TABLET in 1 BOTTLE (62559-650-90) 90 tablet2018-10-010000-00-00NoNoCurrent