FDA.reportPublic FDA data

HYDROCHLOROTHIAZIDE

Product NDC
61919-293
11-digit product format
619190293
Labeler code
61919
Product ID
61919-293_f2122b79-79b2-45e0-e053-2995a90a3d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040907
Marketing category
ANDA
Marketing start
2019-08-21
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 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
61919-293-032025-01-30C16284748780-12cef2736-70eb-d83d-e063-dadaa90ab31fHYDROCHLOROTHIAZIDE
61919-293-152025-01-30C16284748780-12cef2736-70eb-d83d-e063-dadaa90ab31fHYDROCHLOROTHIAZIDE
61919-293-202020-01-31C16284748780-19d75b9cf-f671-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-293-302020-01-31C16284748780-19d75b9cf-f671-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-293-602020-01-31C16284748780-19d75b9cf-f671-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-293-712020-01-31C16284748780-19d75b9cf-f671-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-293-902020-01-31C16284748780-19d75b9cf-f671-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-293-03HYDROCHLOROTHIAZIDE3 in 1 BOTTLETABLET37
61919-293-15HYDROCHLOROTHIAZIDE15 in 1 BOTTLETABLET157
61919-293-20HYDROCHLOROTHIAZIDE20 in 1 BOTTLETABLET203
61919-293-30HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET303
61919-293-60HYDROCHLOROTHIAZIDE60 in 1 BOTTLETABLET603
61919-293-71HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET1003
61919-293-90HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-293-03EA - Each61919-293750ef8d9-3e1d-4c56-b82c-33ca48b6f36612021-01-08
61919-293-20EA - Each61919-293a48af1a3-4d15-448a-a873-d0d9dcc1bf6212015-11-12
61919-293-30EA - Each61919-293ebeb4f2d-01d5-4860-8f33-8e9400ced52212014-08-01
61919-293-60EA - Each61919-293149b22c3-7906-486a-9144-dc9c864ca9ac12015-11-12
61919-293-90EA - Each61919-2933574009f-d351-48ce-a868-9edcdc3f621512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-293HYDROCHLOROTHIAZIDE TABLET [DIRECT_RX]7Legacy NDC, 2 package rows20230418_90a07625-214d-741f-e053-2a95a90a2832.zip
61919-293HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3Legacy NDC, 5 package rows20151106_5d56f7bc-96bd-47f4-8133-be7656f216c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN90a07625-214d-741f-e053-2a95a90a28327
310798hydrochlorothiazide 25 MG Oral TabletSCD90a07625-214d-741f-e053-2a95a90a28327
310798HCTZ 25 MG Oral TabletSY90a07625-214d-741f-e053-2a95a90a28327
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5d56f7bc-96bd-47f4-8133-be7656f216c73
310798hydrochlorothiazide 25 MG Oral TabletSCD5d56f7bc-96bd-47f4-8133-be7656f216c73
310798HCTZ 25 MG Oral TabletSY5d56f7bc-96bd-47f4-8133-be7656f216c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-293-03619190293033 TABLET in 1 BOTTLE (61919-293-03) 3 tablet2019-08-210000-00-00NoNoCurrent
61919-293-156191902931515 TABLET in 1 BOTTLE (61919-293-15) 15 tablet2019-08-210000-00-00NoNoCurrent
61919-293-206191902932020 in 1 BOTTLEHistorical
61919-293-306191902933030 in 1 BOTTLEHistorical
61919-293-606191902936060 in 1 BOTTLEHistorical
61919-293-7161919029371100 in 1 BOTTLEHistorical
61919-293-906191902939090 in 1 BOTTLEHistorical