FDA.reportPublic FDA data

AMLODIPINE AND VALSARTAN

Product NDC
43386-081
11-digit product format
433860081
Labeler code
43386
Product ID
43386-081_8d66a9ba-050e-4993-939b-f2c858760a0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA202829
Marketing category
ANDA
Marketing start
2015-03-30
Substance
AMLODIPINE BESYLATE; VALSARTAN
Active strength
5; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE AND VALSARTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I, 864V2Q084H
Rxcui722126, 722131, 722134, 722137

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43386-081-032023-01-31C16284748780-1f386c64a-3a1c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Amlodipine and Valsartan Tablets safely and effectively. See full prescribing information for Amlodipine and Valsartan Tablets. AMLODIPINE and VALSARTAN tablets, for oral use Initial U.S. Approval: 2007
43386-081-092023-01-31C16284748780-1f386c64a-3a1c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Amlodipine and Valsartan Tablets safely and effectively. See full prescribing information for Amlodipine and Valsartan Tablets. AMLODIPINE and VALSARTAN tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-081-03AMLODIPINE AND VALSARTAN30 in 1 BOTTLETABLET304
43386-081-09AMLODIPINE AND VALSARTAN90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-081-03EA - Each43386-081927c919d-78bf-451f-ad65-1e9a2216fa9712015-05-05
43386-081-09EA - Each43386-081721bc99c-d793-4139-b2d9-4e0dd672c0dd12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
VALSARTANACTIVE INGREDIENT80M03YXJ7IAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
VALSARTANACTIVE MOIETY80M03YXJ7IAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-081AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [LUPIN PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20230201_e05dd72c-7475-422e-bf8e-73148929450e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722126amLODIPine 10 MG / valsartan 160 MG Oral TabletPSNe05dd72c-7475-422e-bf8e-73148929450e4
722131amLODIPine 10 MG / valsartan 320 MG Oral TabletPSNe05dd72c-7475-422e-bf8e-73148929450e4
722134amLODIPine 5 MG / valsartan 160 MG Oral TabletPSNe05dd72c-7475-422e-bf8e-73148929450e4
722137amLODIPine 5 MG / valsartan 320 MG Oral TabletPSNe05dd72c-7475-422e-bf8e-73148929450e4
722126amlodipine 10 MG / valsartan 160 MG Oral TabletSCDe05dd72c-7475-422e-bf8e-73148929450e4
722131amlodipine 10 MG / valsartan 320 MG Oral TabletSCDe05dd72c-7475-422e-bf8e-73148929450e4
722134amlodipine 5 MG / valsartan 160 MG Oral TabletSCDe05dd72c-7475-422e-bf8e-73148929450e4
722137amlodipine 5 MG / valsartan 320 MG Oral TabletSCDe05dd72c-7475-422e-bf8e-73148929450e4
722126amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral TabletSYe05dd72c-7475-422e-bf8e-73148929450e4
722131amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral TabletSYe05dd72c-7475-422e-bf8e-73148929450e4
722134amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral TabletSYe05dd72c-7475-422e-bf8e-73148929450e4
722137amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral TabletSYe05dd72c-7475-422e-bf8e-73148929450e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-081-034338600810330 TABLET in 1 BOTTLE (43386-081-03) 30 tablet2015-03-300000-00-00NoNoCurrent
43386-081-094338600810990 TABLET in 1 BOTTLE (43386-081-09) 90 tablet2015-03-300000-00-00NoNoCurrent