FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
43353-719
11-digit product format
433530719
Labeler code
43353
Product ID
43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA083177
Marketing category
ANDA
Marketing start
1973-01-12
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
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
Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui197770, 310798

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
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
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
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
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-719-15Hydrochlorothiazide15 in 1 BOTTLETABLET152
43353-719-30Hydrochlorothiazide30 in 1 BOTTLETABLET302
43353-719-45Hydrochlorothiazide45 in 1 BOTTLETABLET452
43353-719-53Hydrochlorothiazide60 in 1 BOTTLETABLET602
43353-719-60Hydrochlorothiazide90 in 1 BOTTLETABLET902
43353-719-65Hydrochlorothiazide100 in 1 BOTTLETABLET1002
43353-719-73Hydrochlorothiazide135 in 1 BOTTLETABLET1352
43353-719-80Hydrochlorothiazide180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-719HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 8 package rows20171017_61487122-8a94-4ad5-a307-7893e0b7510c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN61487122-8a94-4ad5-a307-7893e0b7510c2
197770hydroCHLOROthiazide 50 MG Oral TabletPSN61487122-8a94-4ad5-a307-7893e0b7510c2
310798hydrochlorothiazide 25 MG Oral TabletSCD61487122-8a94-4ad5-a307-7893e0b7510c2
197770hydrochlorothiazide 50 MG Oral TabletSCD61487122-8a94-4ad5-a307-7893e0b7510c2
310798HCTZ 25 MG Oral TabletSY61487122-8a94-4ad5-a307-7893e0b7510c2
197770HCTZ 50 MG Oral TabletSY61487122-8a94-4ad5-a307-7893e0b7510c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-719-154335307191515 TABLET in 1 BOTTLE (43353-719-15) 15 tablet2011-04-130000-00-00NoNoCurrent
43353-719-304335307193030 TABLET in 1 BOTTLE (43353-719-30) 30 tablet2011-04-130000-00-00NoNoCurrent
43353-719-454335307194545 TABLET in 1 BOTTLE (43353-719-45) 45 tablet2011-04-130000-00-00NoNoCurrent
43353-719-534335307195360 TABLET in 1 BOTTLE (43353-719-53) 60 tablet2011-04-130000-00-00NoNoCurrent
43353-719-604335307196090 TABLET in 1 BOTTLE (43353-719-60) 90 tablet2011-04-130000-00-00NoNoCurrent
43353-719-6543353071965100 TABLET in 1 BOTTLE (43353-719-65) 100 tablet2011-04-130000-00-00NoNoCurrent
43353-719-7343353071973135 TABLET in 1 BOTTLE (43353-719-73) 135 tablet2011-04-130000-00-00NoNoCurrent
43353-719-8043353071980180 TABLET in 1 BOTTLE (43353-719-80) 180 tablet2011-04-130000-00-00NoNoCurrent