FDA.reportPublic FDA data

HYDROCHLOROTHIAZIDE

Product NDC
69315-155
11-digit product format
693150155
Labeler code
69315
Product ID
69315-155_001b600e-a6f4-4f39-bdd3-cf29fb96fa83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA040702
Marketing category
ANDA
Marketing start
2019-11-01
Substance
HYDROCHLOROTHIAZIDE
Active strength
12.5 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
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui197770, 310798, 429503

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
69315-155-01HYDROCHLOROTHIAZIDE100 in 1 BOTTLE, PLASTICTABLET10016
69315-155-10HYDROCHLOROTHIAZIDE1000 in 1 BOTTLE, PLASTICTABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-155-01EA - Each69315-155637c42b6-816a-4a91-b07d-590badaad67d12019-11-12
69315-155-10EA - Each69315-1555e632c8e-23db-4d8f-9187-06a4d22182f512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-155HYDROCHLOROTHIAZIDE TABLET [LEADING PHARMA, LLC]16Current NDC, Legacy NDC, 2 package rows20240731_8c868894-667e-4a51-906a-838d63e420ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN03b7e52e-0003-47c3-af12-93ef00800b37102
429503hydrochlorothiazide 12.5 MG Oral TabletSCD03b7e52e-0003-47c3-af12-93ef00800b37102
429503HCTZ 12.5 MG Oral TabletSY03b7e52e-0003-47c3-af12-93ef00800b37102
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN8c868894-667e-4a51-906a-838d63e420ba16
310798hydroCHLOROthiazide 25 MG Oral TabletPSN8c868894-667e-4a51-906a-838d63e420ba16
197770hydroCHLOROthiazide 50 MG Oral TabletPSN8c868894-667e-4a51-906a-838d63e420ba16
429503hydrochlorothiazide 12.5 MG Oral TabletSCD8c868894-667e-4a51-906a-838d63e420ba16
310798hydrochlorothiazide 25 MG Oral TabletSCD8c868894-667e-4a51-906a-838d63e420ba16
197770hydrochlorothiazide 50 MG Oral TabletSCD8c868894-667e-4a51-906a-838d63e420ba16
429503HCTZ 12.5 MG Oral TabletSY8c868894-667e-4a51-906a-838d63e420ba16
310798HCTZ 25 MG Oral TabletSY8c868894-667e-4a51-906a-838d63e420ba16
197770HCTZ 50 MG Oral TabletSY8c868894-667e-4a51-906a-838d63e420ba16
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNa85f69f5-ba97-478d-e053-2a95a90a0a979
310798hydroCHLOROthiazide 25 MG Oral TabletPSNa85f69f5-ba97-478d-e053-2a95a90a0a979
197770hydroCHLOROthiazide 50 MG Oral TabletPSNa85f69f5-ba97-478d-e053-2a95a90a0a979
429503hydrochlorothiazide 12.5 MG Oral TabletSCDa85f69f5-ba97-478d-e053-2a95a90a0a979
310798hydrochlorothiazide 25 MG Oral TabletSCDa85f69f5-ba97-478d-e053-2a95a90a0a979
197770hydrochlorothiazide 50 MG Oral TabletSCDa85f69f5-ba97-478d-e053-2a95a90a0a979
429503HCTZ 12.5 MG Oral TabletSYa85f69f5-ba97-478d-e053-2a95a90a0a979
310798HCTZ 25 MG Oral TabletSYa85f69f5-ba97-478d-e053-2a95a90a0a979
197770HCTZ 50 MG Oral TabletSYa85f69f5-ba97-478d-e053-2a95a90a0a979
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN4c1a92c0-b491-4ae9-8bd0-029beb2b13c65
429503hydrochlorothiazide 12.5 MG Oral TabletSCD4c1a92c0-b491-4ae9-8bd0-029beb2b13c65
429503HCTZ 12.5 MG Oral TabletSY4c1a92c0-b491-4ae9-8bd0-029beb2b13c65
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNf331769a-ff11-6c68-e053-2a95a90a493b4
429503hydrochlorothiazide 12.5 MG Oral TabletSCDf331769a-ff11-6c68-e053-2a95a90a493b4
429503HCTZ 12.5 MG Oral TabletSYf331769a-ff11-6c68-e053-2a95a90a493b4
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN71691ccf-0ed9-4a14-8da6-7ab9b9698f522
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNf9faec8a-2b71-47bb-a296-48ecbce9af502
429503hydrochlorothiazide 12.5 MG Oral TabletSCDf9faec8a-2b71-47bb-a296-48ecbce9af502
429503hydrochlorothiazide 12.5 MG Oral TabletSCD71691ccf-0ed9-4a14-8da6-7ab9b9698f522
429503HCTZ 12.5 MG Oral TabletSYf9faec8a-2b71-47bb-a296-48ecbce9af502
429503HCTZ 12.5 MG Oral TabletSY71691ccf-0ed9-4a14-8da6-7ab9b9698f522
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN93f6a018-8b3d-4f40-be25-902daec19aea1
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN099496f1-4e2d-8d21-e063-6294a90af6951
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN1884db5f-72b5-6b0c-e063-6394a90a0e491
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN1e02787f-ccb5-abc2-e063-6294a90af7c31
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN2dd7c2a4-d335-4c6f-b1e6-b0ae6eebab841
429503hydrochlorothiazide 12.5 MG Oral TabletSCD2dd7c2a4-d335-4c6f-b1e6-b0ae6eebab841
429503hydrochlorothiazide 12.5 MG Oral TabletSCD1e02787f-ccb5-abc2-e063-6294a90af7c31
429503hydrochlorothiazide 12.5 MG Oral TabletSCD1884db5f-72b5-6b0c-e063-6394a90a0e491
429503hydrochlorothiazide 12.5 MG Oral TabletSCD099496f1-4e2d-8d21-e063-6294a90af6951
429503hydrochlorothiazide 12.5 MG Oral TabletSCD93f6a018-8b3d-4f40-be25-902daec19aea1
429503HCTZ 12.5 MG Oral TabletSY1e02787f-ccb5-abc2-e063-6294a90af7c31
429503HCTZ 12.5 MG Oral TabletSY2dd7c2a4-d335-4c6f-b1e6-b0ae6eebab841
429503HCTZ 12.5 MG Oral TabletSY1884db5f-72b5-6b0c-e063-6394a90a0e491
429503HCTZ 12.5 MG Oral TabletSY099496f1-4e2d-8d21-e063-6294a90af6951
429503HCTZ 12.5 MG Oral TabletSY93f6a018-8b3d-4f40-be25-902daec19aea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-155-0169315015501100 TABLET in 1 BOTTLE, PLASTIC (69315-155-01) 100 tablet2019-11-010000-00-00NoNoCurrent
69315-155-10693150155101000 TABLET in 1 BOTTLE, PLASTIC (69315-155-10) 1000 tablet2019-11-010000-00-00NoNoCurrent