FDA.reportPublic FDA data

Exforge

Product NDC
0078-0491
11-digit product format
000780491
Labeler code
0078
Product ID
0078-0491_7e675018-c404-4ea5-ac95-a18d7cb78301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021990
Marketing category
NDA
Marketing start
2007-06-20
Substance
AMLODIPINE BESYLATE; VALSARTAN
Active strength
10; 320 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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Exforge
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 80M03YXJ7I
Rxcui722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895

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
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
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
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0491-15Exforge30 in 1 BOTTLETABLET, FILM COATED3036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0491-15EA - Each0078-04913fcfcb93-42da-4d4d-9c42-e937a8dc44b212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE INGREDIENT80M03YXJ7IEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
AMLODIPINEACTIVE MOIETY1J444QC288EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE MOIETY80M03YXJ7IEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TALCINACTIVE INGREDIENT7SEV7J4R1UEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
VALSARTANACTIVE INGREDIENT80M03YXJ7IEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
AMLODIPINEACTIVE MOIETY1J444QC288EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
VALSARTANACTIVE MOIETY80M03YXJ7IEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0491EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]34Current NDC, Legacy NDC, 1 package rows20250406_d0caec89-96ec-411d-a933-63eda74a6da7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722126amLODIPine 10 MG / valsartan 160 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
722131amLODIPine 10 MG / valsartan 320 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
722134amLODIPine 5 MG / valsartan 160 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
722137amLODIPine 5 MG / valsartan 320 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
724879EXFORGE 10 MG / 160 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
724887EXFORGE 10 MG / 320 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
724891EXFORGE 5 MG / 160 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
724895EXFORGE 5 MG / 320 MG Oral TabletPSNd0caec89-96ec-411d-a933-63eda74a6da736
724879amlodipine 10 MG / valsartan 160 MG Oral Tablet [Exforge]SBDd0caec89-96ec-411d-a933-63eda74a6da736
724887amlodipine 10 MG / valsartan 320 MG Oral Tablet [Exforge]SBDd0caec89-96ec-411d-a933-63eda74a6da736
724891amlodipine 5 MG / valsartan 160 MG Oral Tablet [Exforge]SBDd0caec89-96ec-411d-a933-63eda74a6da736
724895amlodipine 5 MG / valsartan 320 MG Oral Tablet [Exforge]SBDd0caec89-96ec-411d-a933-63eda74a6da736
722126amlodipine 10 MG / valsartan 160 MG Oral TabletSCDd0caec89-96ec-411d-a933-63eda74a6da736
722131amlodipine 10 MG / valsartan 320 MG Oral TabletSCDd0caec89-96ec-411d-a933-63eda74a6da736
722134amlodipine 5 MG / valsartan 160 MG Oral TabletSCDd0caec89-96ec-411d-a933-63eda74a6da736
722137amlodipine 5 MG / valsartan 320 MG Oral TabletSCDd0caec89-96ec-411d-a933-63eda74a6da736
722126amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
722131amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
722134amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
722137amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724879Exforge 10/160 (amlodipine / valsartan) Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724879Exforge 10/160 Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724887Exforge 10/320 (amlodipine / valsartan) Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724887Exforge 10/320 Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724891Exforge 5/160 (amlodipine / valsartan) Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724891Exforge 5/160 Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724895Exforge 5/320 (amlodipine / valsartan) Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
724895Exforge 5/320 Oral TabletSYd0caec89-96ec-411d-a933-63eda74a6da736
722126amLODIPine 10 MG / valsartan 160 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722131amLODIPine 10 MG / valsartan 320 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722134amLODIPine 5 MG / valsartan 160 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722137amLODIPine 5 MG / valsartan 320 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724879EXFORGE 10 MG / 160 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724887EXFORGE 10 MG / 320 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724891EXFORGE 5 MG / 160 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724895EXFORGE 5 MG / 320 MG Oral TabletPSN15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724879amlodipine 10 MG / valsartan 160 MG Oral Tablet [Exforge]SBD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724887amlodipine 10 MG / valsartan 320 MG Oral Tablet [Exforge]SBD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724891amlodipine 5 MG / valsartan 160 MG Oral Tablet [Exforge]SBD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724895amlodipine 5 MG / valsartan 320 MG Oral Tablet [Exforge]SBD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722126amlodipine 10 MG / valsartan 160 MG Oral TabletSCD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722131amlodipine 10 MG / valsartan 320 MG Oral TabletSCD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722134amlodipine 5 MG / valsartan 160 MG Oral TabletSCD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722137amlodipine 5 MG / valsartan 320 MG Oral TabletSCD15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722126amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722131amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722134amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
722137amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724879Exforge 10/160 (amlodipine / valsartan) Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724879Exforge 10/160 Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724887Exforge 10/320 (amlodipine / valsartan) Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724887Exforge 10/320 Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724891Exforge 5/160 (amlodipine / valsartan) Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724891Exforge 5/160 Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724895Exforge 5/320 (amlodipine / valsartan) Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6
724895Exforge 5/320 Oral TabletSY15ba7c1c-dd10-4d09-b6e2-284c1b67f4da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0491-150007804911530 TABLET, FILM COATED in 1 BOTTLE (0078-0491-15) 2007-06-200000-00-00NoNoCurrent