FDA.reportPublic FDA data

ATACAND HCT

Product NDC
0186-0162
11-digit product format
001860162
Labeler code
0186
Product ID
0186-0162_9e314974-b835-461b-b4f4-9f3660ea83ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021093
Marketing category
NDA
Marketing start
2000-09-28
Marketing end
2019-07-31
Substance
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength
16 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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-0162-28EA - Each0186-0162e6574eed-1ff8-41a0-8a9c-a970d09a1cc412012-07-24
0186-0162-54EA - Each0186-0162b6a5da02-9fd2-4eef-ab24-a9935b571b1312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CANDESARTAN CILEXETILACTIVE INGREDIENTR85M2X0D68ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CANDESARTANACTIVE MOIETYS8Q36MD2XXATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805863Atacand HCT 16 MG / 12.5 MG Oral TabletPSN8e50e65d-b79b-46b4-a147-796cb19f14072
805859Atacand HCT 32 MG / 12.5 MG Oral TabletPSN8e50e65d-b79b-46b4-a147-796cb19f14072
578325candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8e50e65d-b79b-46b4-a147-796cb19f14072
578330candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8e50e65d-b79b-46b4-a147-796cb19f14072
805863candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Atacand HCT]SBD8e50e65d-b79b-46b4-a147-796cb19f14072
805859candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Atacand HCT]SBD8e50e65d-b79b-46b4-a147-796cb19f14072
578325candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD8e50e65d-b79b-46b4-a147-796cb19f14072
578330candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD8e50e65d-b79b-46b4-a147-796cb19f14072
805863Atacand HCT 16/12.5 Oral TabletSY8e50e65d-b79b-46b4-a147-796cb19f14072
805859Atacand HCT 32/12.5 Oral TabletSY8e50e65d-b79b-46b4-a147-796cb19f14072
578325candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral TabletSY8e50e65d-b79b-46b4-a147-796cb19f14072
805863candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral Tablet [Atacand HCT]SY8e50e65d-b79b-46b4-a147-796cb19f14072
578330candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral TabletSY8e50e65d-b79b-46b4-a147-796cb19f14072
805859candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral Tablet [Atacand HCT]SY8e50e65d-b79b-46b4-a147-796cb19f14072