FDA.reportPublic FDA data

HYDROCHLOROTHIAZIDE

Product NDC
61919-580
11-digit product format
619190580
Labeler code
61919
Product ID
61919-580_f214c893-efe7-b30b-e053-2a95a90a4fb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090510
Marketing category
ANDA
Marketing start
2019-08-21
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-580-902025-01-30C16284748780-12cef2736-8f95-d83d-e063-dadaa90ab31fHYDROCHLOROTHIAZIDE
61919-580-302020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-580-712020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-580-30HYDROCHLOROTHIAZIDE30 in 1 BOTTLECAPSULE304
61919-580-71HYDROCHLOROTHIAZIDE100 in 1 BOTTLECAPSULE1004
61919-580-90HYDROCHLOROTHIAZIDE90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-580-30EA - Each61919-5803eb530af-f45c-40c2-9e31-59619685aa8712015-03-03
61919-580-71EA - Each61919-5804b40713b-fce9-4b1c-a316-9af5b6b95a4712015-11-12
61919-580-90EA - Each61919-580dca9282c-17ce-48b7-8329-2f3765947f0e12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]4Legacy NDC, 2 package rows20161020_b0f2e5c7-2135-4154-bde7-9080e95d3e91.zip
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT_RX]4Legacy NDC, 1 package rows20230113_90a0a64c-1c98-f27b-e053-2a95a90a8ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903HCTZ 12.5 MG Oral CapsuleSY90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903HCTZ 12.5 MG Oral CapsuleSYb0f2e5c7-2135-4154-bde7-9080e95d3e914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-580-306191905803030 in 1 BOTTLEHistorical
61919-580-7161919058071100 in 1 BOTTLEHistorical
61919-580-906191905809090 CAPSULE in 1 BOTTLE (61919-580-90) 90 capsule2019-08-210000-00-00NoNoCurrent