FDA.reportPublic FDA data

Amlodipine and Valsartan

Product NDC
23155-844
11-digit product format
231550844
Labeler code
23155
Product ID
23155-844_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090011
Marketing category
ANDA
Marketing start
2023-03-15
Substance
AMLODIPINE; VALSARTAN
Active strength
5; 160 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
AMLODIPINE5 mg/1
VALSARTAN160 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-844-03Amlodipine and Valsartan30 in 1 BOTTLE, PLASTICTABLET305
23155-844-09Amlodipine and Valsartan90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-844-03EA - Each23155-844dbc262ff-6dd5-4f35-9422-8d920624160412023-04-07
23155-844-09EA - Each23155-844ca4d3dd0-c940-4d46-8553-c8c4112963e512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-844AMLODIPINE AND VALSARTAN TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 2 package rows20241121_55a1d22e-04ad-4475-9b05-0d534e289160.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
722126amLODIPine 10 MG / valsartan 160 MG Oral TabletPSN55a1d22e-04ad-4475-9b05-0d534e2891605
722131amLODIPine 10 MG / valsartan 320 MG Oral TabletPSN55a1d22e-04ad-4475-9b05-0d534e2891605
722134amLODIPine 5 MG / valsartan 160 MG Oral TabletPSN55a1d22e-04ad-4475-9b05-0d534e2891605
722137amLODIPine 5 MG / valsartan 320 MG Oral TabletPSN55a1d22e-04ad-4475-9b05-0d534e2891605
722126amlodipine 10 MG / valsartan 160 MG Oral TabletSCD55a1d22e-04ad-4475-9b05-0d534e2891605
722131amlodipine 10 MG / valsartan 320 MG Oral TabletSCD55a1d22e-04ad-4475-9b05-0d534e2891605
722134amlodipine 5 MG / valsartan 160 MG Oral TabletSCD55a1d22e-04ad-4475-9b05-0d534e2891605
722137amlodipine 5 MG / valsartan 320 MG Oral TabletSCD55a1d22e-04ad-4475-9b05-0d534e2891605
722126amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral TabletSY55a1d22e-04ad-4475-9b05-0d534e2891605
722131amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral TabletSY55a1d22e-04ad-4475-9b05-0d534e2891605
722134amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral TabletSY55a1d22e-04ad-4475-9b05-0d534e2891605
722137amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral TabletSY55a1d22e-04ad-4475-9b05-0d534e2891605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-844-032315508440330 TABLET in 1 BOTTLE, PLASTIC (23155-844-03) 30 tablet2023-03-15NoNoCurrent
23155-844-092315508440990 TABLET in 1 BOTTLE, PLASTIC (23155-844-09) 90 tablet2023-03-15NoNoCurrent