FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
64125-130
11-digit product format
641250130
Labeler code
64125
Product ID
64125-130_85594a90-366d-4d66-8d80-218dffef94d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Excellium Pharmaceutical Inc.
Application
ANDA040702
Marketing category
ANDA
Marketing start
2007-06-01
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
64125-130-012019-11-13C16284748780-197449f38-c04d-f6ea-e053-dbdaa90aa703HYDROCHLOROTHIAZIDE TABLETS, USP Rx only
64125-130-102019-11-13C16284748780-197449f38-c04d-f6ea-e053-dbdaa90aa703HYDROCHLOROTHIAZIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64125-130-01Hydrochlorothiazide100 in 1 BOTTLETABLET1002
64125-130-10Hydrochlorothiazide1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64125-130-01EA - Each64125-1309a71d1cc-4b86-4be8-b8a3-e8cdbc56ec4612013-02-13
64125-130-10EA - Each64125-130c06688bd-6cdf-4f1b-aac3-52548b0b2e6212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64125-130HYDROCHLOROTHIAZIDE TABLET [EXCELLIUM PHARMACEUTICAL INC.]2Legacy NDC, 2 package rows20120905_4ca95d04-765a-47a8-8118-48c7740f4e81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN6be05675-c4b4-4e1e-9047-044a7fc7cef65
197770hydroCHLOROthiazide 50 MG Oral TabletPSN6be05675-c4b4-4e1e-9047-044a7fc7cef65
310798hydrochlorothiazide 25 MG Oral TabletSCD6be05675-c4b4-4e1e-9047-044a7fc7cef65
197770hydrochlorothiazide 50 MG Oral TabletSCD6be05675-c4b4-4e1e-9047-044a7fc7cef65
310798HCTZ 25 MG Oral TabletSY6be05675-c4b4-4e1e-9047-044a7fc7cef65
197770HCTZ 50 MG Oral TabletSY6be05675-c4b4-4e1e-9047-044a7fc7cef65
310798hydroCHLOROthiazide 25 MG Oral TabletPSN4ca95d04-765a-47a8-8118-48c7740f4e812
197770hydroCHLOROthiazide 50 MG Oral TabletPSN4ca95d04-765a-47a8-8118-48c7740f4e812
310798hydrochlorothiazide 25 MG Oral TabletSCD4ca95d04-765a-47a8-8118-48c7740f4e812
197770hydrochlorothiazide 50 MG Oral TabletSCD4ca95d04-765a-47a8-8118-48c7740f4e812
310798HCTZ 25 MG Oral TabletSY4ca95d04-765a-47a8-8118-48c7740f4e812
197770HCTZ 50 MG Oral TabletSY4ca95d04-765a-47a8-8118-48c7740f4e812
310798hydroCHLOROthiazide 25 MG Oral TabletPSNfe6200cc-3182-473c-a90a-a8caa2fb28181
310798hydroCHLOROthiazide 25 MG Oral TabletPSNe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
197770hydroCHLOROthiazide 50 MG Oral TabletPSNe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
197770hydroCHLOROthiazide 50 MG Oral TabletPSNfe6200cc-3182-473c-a90a-a8caa2fb28181
310798hydrochlorothiazide 25 MG Oral TabletSCDfe6200cc-3182-473c-a90a-a8caa2fb28181
310798hydrochlorothiazide 25 MG Oral TabletSCDe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
197770hydrochlorothiazide 50 MG Oral TabletSCDfe6200cc-3182-473c-a90a-a8caa2fb28181
197770hydrochlorothiazide 50 MG Oral TabletSCDe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
310798HCTZ 25 MG Oral TabletSYe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
310798HCTZ 25 MG Oral TabletSYfe6200cc-3182-473c-a90a-a8caa2fb28181
197770HCTZ 50 MG Oral TabletSYe57a1fb3-1bf5-4562-982c-52a6f5fb36ed1
197770HCTZ 50 MG Oral TabletSYfe6200cc-3182-473c-a90a-a8caa2fb28181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64125-130-0164125013001100 in 1 BOTTLEHistorical
64125-130-10641250130101000 in 1 BOTTLEHistorical