FDA.reportPublic FDA data

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Product NDC
64380-199
11-digit product format
643800199
Labeler code
64380
Product ID
64380-199_6c98cab6-e7ba-42ba-adf9-71fa67c0a403
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate valsartan hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA201087
Marketing category
ANDA
Marketing start
2022-06-27
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
10; 12.5; 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
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1
VALSARTAN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I, 0J48LPH2TH, 864V2Q084H
Rxcui848131, 848135, 848140, 848145, 848151

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-199-012024-04-24C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-199-022024-04-24C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-199-032024-04-24C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-199-012024-01-30C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-199-022024-01-30C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-199-032024-01-30C16284748780-11030e365-276f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-199-01AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED306
64380-199-02AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED906
64380-199-03AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-199-01EA - Each64380-199d0ec3891-9e46-4358-96c8-556ba913c99b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-199AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 3 package rows20250411_9b76e441-e6a5-4036-8276-b7788ade5c44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848131amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9b76e441-e6a5-4036-8276-b7788ade5c446
848151amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9b76e441-e6a5-4036-8276-b7788ade5c446
848135amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9b76e441-e6a5-4036-8276-b7788ade5c446
848140amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN9b76e441-e6a5-4036-8276-b7788ade5c446
848145amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9b76e441-e6a5-4036-8276-b7788ade5c446
848131amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD9b76e441-e6a5-4036-8276-b7788ade5c446
848151amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD9b76e441-e6a5-4036-8276-b7788ade5c446
848135amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD9b76e441-e6a5-4036-8276-b7788ade5c446
848140amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD9b76e441-e6a5-4036-8276-b7788ade5c446
848145amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD9b76e441-e6a5-4036-8276-b7788ade5c446
848131amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848135amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848151amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848140amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848145amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848131amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848151amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848135amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848140amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848145amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSY9b76e441-e6a5-4036-8276-b7788ade5c446
848131amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe9ecbadb-c548-6fe5-e053-2a95a90a75773
848151amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe9ecbadb-c548-6fe5-e053-2a95a90a75773
848135amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe9ecbadb-c548-6fe5-e053-2a95a90a75773
848140amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe9ecbadb-c548-6fe5-e053-2a95a90a75773
848145amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe9ecbadb-c548-6fe5-e053-2a95a90a75773
848131amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDe9ecbadb-c548-6fe5-e053-2a95a90a75773
848151amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDe9ecbadb-c548-6fe5-e053-2a95a90a75773
848135amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDe9ecbadb-c548-6fe5-e053-2a95a90a75773
848140amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDe9ecbadb-c548-6fe5-e053-2a95a90a75773
848145amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDe9ecbadb-c548-6fe5-e053-2a95a90a75773
848131amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848135amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848151amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848140amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848145amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848131amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848151amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848135amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848140amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773
848145amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral TabletSYe9ecbadb-c548-6fe5-e053-2a95a90a75773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-199-016438001990130 TABLET, FILM COATED in 1 BOTTLE (64380-199-01) 2022-06-270000-00-00NoNoCurrent
64380-199-026438001990290 TABLET, FILM COATED in 1 BOTTLE (64380-199-02) 2022-06-270000-00-00NoNoCurrent
64380-199-0364380019903500 TABLET, FILM COATED in 1 BOTTLE (64380-199-03) 2022-06-270000-00-00NoNoCurrent