FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
50090-0140
11-digit product format
500900140
Labeler code
50090
Product ID
50090-0140_39b71216-ca07-49f0-8a51-0fccf400dc2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040907
Marketing category
ANDA
Marketing start
2008-08-15
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui310798

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
50090-0140-02023-08-25C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
50090-0140-12023-08-25C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
50090-0140-82023-08-25C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
50090-0140-02023-01-30C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
50090-0140-12023-01-30C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
50090-0140-82023-01-30C16284748780-1f386c649-d17c-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0140-0Hydrochlorothiazide30 in 1 BOTTLETABLET3017
50090-0140-1Hydrochlorothiazide100 in 1 BOTTLETABLET10017
50090-0140-8Hydrochlorothiazide200 in 1 BOTTLETABLET20017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0140-0EA - Each50090-01405111d83c-f615-4fe4-b7a9-88553dc7d77f12021-05-05
50090-0140-1EA - Each50090-014054f7a2d5-3b27-4528-a957-7fb7f78a660a12021-05-05
50090-0140-8EA - Each50090-01402bb61eb3-a0bf-4ba4-afbe-f05dd027d9bc12023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0140HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 3 package rows20230920_96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17
310798hydrochlorothiazide 25 MG Oral TabletSCD96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17
310798HCTZ 25 MG Oral TabletSY96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0140-05009001400030 TABLET in 1 BOTTLE (50090-0140-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0140-150090014001100 TABLET in 1 BOTTLE (50090-0140-1) 100 tablet2014-11-280000-00-00NoNoCurrent
50090-0140-850090014008200 TABLET in 1 BOTTLE (50090-0140-8) 200 tablet2014-11-280000-00-00NoNoCurrent