FDA.reportPublic FDA data

VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC
43547-312
11-digit product format
435470312
Labeler code
43547
Product ID
43547-312_2d03a607-2ffd-4df1-8c94-bec2b786709c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA206083
Marketing category
ANDA
Marketing start
2015-10-31
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
12.5; 160 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VALSARTAN AND HYDROCHLOROTHIAZIDE
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 80M03YXJ7I
Rxcui200284, 200285, 349353, 636042, 636045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
89dac932-b90a-4410-9ab1-84c53e57de25Product 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
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-312-03VALSARTAN AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED3023
43547-312-09VALSARTAN AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED9023
43547-312-50VALSARTAN AND HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-312-09EA - Each43547-312d0d6b098-f1e7-4e4b-9751-25b4af3a6e9a12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-312VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]22Current NDC, Legacy NDC, 3 package rows20230619_f8b0a8ab-4549-4553-a127-bf2c0291a4b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNf8b0a8ab-4549-4553-a127-bf2c0291a4b123
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCDf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDf8b0a8ab-4549-4553-a127-bf2c0291a4b123
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSYf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYf8b0a8ab-4549-4553-a127-bf2c0291a4b123
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYf8b0a8ab-4549-4553-a127-bf2c0291a4b123
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYf8b0a8ab-4549-4553-a127-bf2c0291a4b123
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd09747f0-029e-4090-949b-e939948249b53
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN3131809e-885a-42d3-b6ad-1b208fd3ba563
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDd09747f0-029e-4090-949b-e939948249b53
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD3131809e-885a-42d3-b6ad-1b208fd3ba563
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYd09747f0-029e-4090-949b-e939948249b53
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY3131809e-885a-42d3-b6ad-1b208fd3ba563
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd55b2f01-5cd1-40bb-8d36-34b5b9081ddc1
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDd55b2f01-5cd1-40bb-8d36-34b5b9081ddc1
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYd55b2f01-5cd1-40bb-8d36-34b5b9081ddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-312-034354703120330 TABLET, FILM COATED in 1 BOTTLE (43547-312-03) 2021-12-030000-00-00NoNoCurrent
43547-312-094354703120990 TABLET, FILM COATED in 1 BOTTLE (43547-312-09) 2021-12-030000-00-00NoNoCurrent
43547-312-5043547031250500 TABLET, FILM COATED in 1 BOTTLE (43547-312-50) 2021-12-030000-00-00NoNoCurrent