FDA.reportPublic FDA data

Amlodipine and Valsartan

Product NDC
51407-772
11-digit product format
514070772
Labeler code
51407
Product ID
51407-772_4f9c77d6-c13d-7ccb-e063-6394a90ae49f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090011
Marketing category
ANDA
Marketing start
2013-03-28
Substance
AMLODIPINE; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Valsartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE5 mg/1
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I, 1J444QC288
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-772-30Amlodipine and Valsartan30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-772AMLODIPINE AND VALSARTAN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, 1 package rows20250226_fed14445-1117-861a-e053-6294a90a2aa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722126amLODIPine 10 MG / valsartan 160 MG Oral TabletPSNfed14445-1117-861a-e053-6294a90a2aa36
722131amLODIPine 10 MG / valsartan 320 MG Oral TabletPSNfed14445-1117-861a-e053-6294a90a2aa36
722134amLODIPine 5 MG / valsartan 160 MG Oral TabletPSNfed14445-1117-861a-e053-6294a90a2aa36
722137amLODIPine 5 MG / valsartan 320 MG Oral TabletPSNfed14445-1117-861a-e053-6294a90a2aa36
722126amlodipine 10 MG / valsartan 160 MG Oral TabletSCDfed14445-1117-861a-e053-6294a90a2aa36
722131amlodipine 10 MG / valsartan 320 MG Oral TabletSCDfed14445-1117-861a-e053-6294a90a2aa36
722134amlodipine 5 MG / valsartan 160 MG Oral TabletSCDfed14445-1117-861a-e053-6294a90a2aa36
722137amlodipine 5 MG / valsartan 320 MG Oral TabletSCDfed14445-1117-861a-e053-6294a90a2aa36
722126amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral TabletSYfed14445-1117-861a-e053-6294a90a2aa36
722131amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral TabletSYfed14445-1117-861a-e053-6294a90a2aa36
722134amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral TabletSYfed14445-1117-861a-e053-6294a90a2aa36
722137amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral TabletSYfed14445-1117-861a-e053-6294a90a2aa36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-772-305140707723030 TABLET in 1 BOTTLE, PLASTIC (51407-772-30) 30 tablet2023-05-06NoNoCurrent