FDA.reportPublic FDA data

Exforge HCT

Product NDC
0078-0560
11-digit product format
000780560
Labeler code
0078
Product ID
0078-0560_e10fea42-c6e7-4584-9a0a-0709c5323cd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022314
Marketing category
NDA
Marketing start
2009-04-04
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
5; 25; 160 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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
Exforge HCT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
HYDROCHLOROTHIAZIDE25 mg/1
VALSARTAN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 80M03YXJ7I, 0J48LPH2TH
Rxcui848131, 848134, 848135, 848139, 848140, 848144, 848145, 848149, 848151, 848155

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
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
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product 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
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0560-15Exforge HCT30 in 1 BOTTLETABLET, FILM COATED3033
0078-0560-30Exforge HCT30 in 1 CARTONTABLET, FILM COATED3033
0078-0560-30Exforge HCT1 in 1 BLISTER PACKTABLET, FILM COATED133

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0560-15EA - Each0078-05603cb2d03c-6660-45d3-8ae2-59f0d71cbcf312012-07-24
0078-0560-30EA - Each0078-05603c958265-8773-4d05-9a66-fe623c1679d012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
VALSARTANACTIVE INGREDIENT80M03YXJ7IEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
AMLODIPINEACTIVE MOIETY1J444QC288EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
VALSARTANACTIVE MOIETY80M03YXJ7IEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
TALCINACTIVE INGREDIENT7SEV7J4R1UEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0560EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]32Current NDC, Legacy NDC, 3 package rows20250110_18d7820d-471f-4ee2-9ec6-25d8d27c77de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848131amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848151amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848135amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848140amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848145amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848134EXFORGE HCT 10 MG / 160 MG / 12.5 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848155EXFORGE HCT 10 MG / 160 MG / 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848139EXFORGE HCT 10 MG / 320 MG / 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848144EXFORGE HCT 5 MG / 160 MG / 12.5 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848149EXFORGE HCT 5 MG / 160 MG / 25 MG Oral TabletPSN18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848134amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SBD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848155amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SBD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848139amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Exforge HCT]SBD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848144amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SBD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848149amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SBD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848131amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848151amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848135amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848140amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848145amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848131amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848135amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848151amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848140amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848145amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848131amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848134Amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848151amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848155Amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848135amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848139Amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet [Exforge HCT]SY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848140amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848144Amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848145amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848149Amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]SY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848134Exforge HCT 10/160/12.5 (amlodipine / valsartan / HCTZ) Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848134Exforge HCT 10/160/12.5 Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848155Exforge HCT 10/160/25 (amlodipine / valsartan / HCTZ) Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848155Exforge HCT 10/160/25 Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848139Exforge HCT 10/320/25 (amlodipine / valsartan / HCTZ) Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848139Exforge HCT 10/320/25 Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848144Exforge HCT 5/160/12.5 (amlodipine / valsartan / HCTZ) Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848144Exforge HCT 5/160/12.5 Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848149Exforge HCT 5/160/25 (amlodipine / valsartan / HCTZ) Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33
848149Exforge HCT 5/160/25 Oral TabletSY18d7820d-471f-4ee2-9ec6-25d8d27c77de33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0560-150007805601530 TABLET, FILM COATED in 1 BOTTLE (0078-0560-15) 2009-04-040000-00-00NoNoCurrent
0078-0560-300007805603030 in 1 CARTONHistorical