FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
21695-538
11-digit product format
216950538
Labeler code
21695
Product ID
21695-538_256bfee6-3e21-4fdb-a1d0-0ef417b8be86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA084878
Marketing category
ANDA
Marketing start
2006-08-01
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
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
21695-538-002019-09-24C16284748780-1934fe258-4ad3-48b1-e053-8cdaa90a720aHYDROCHLOROTHIAZIDE TABLETS USP Rx Only
21695-538-302019-09-24C16284748780-1934fe258-4ad3-48b1-e053-8cdaa90a720aHYDROCHLOROTHIAZIDE TABLETS USP Rx Only
21695-538-602019-09-24C16284748780-1934fe258-4ad3-48b1-e053-8cdaa90a720aHYDROCHLOROTHIAZIDE TABLETS USP Rx Only
21695-538-902019-09-24C16284748780-1934fe258-4ad3-48b1-e053-8cdaa90a720aHYDROCHLOROTHIAZIDE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-538-00Hydrochlorothiazide100 in 1 BOTTLETABLET1001
21695-538-30Hydrochlorothiazide30 in 1 BOTTLETABLET301
21695-538-60Hydrochlorothiazide60 in 1 BOTTLETABLET601
21695-538-90Hydrochlorothiazide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-538-00EA - Each21695-53817fb6ef4-24fb-4388-8b84-a9ebb0343a2512012-07-24
21695-538-30EA - Each21695-5382b99baba-2ddf-4d4f-87e9-41f85fe536b512012-07-24
21695-538-60EA - Each21695-53893ca6990-68b2-4fa6-b7b8-6608ecfc777312012-07-24
21695-538-90EA - Each21695-53865513406-a2e0-42f9-a2a6-3717e1e406d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-538HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110916_256bfee6-3e21-4fdb-a1d0-0ef417b8be86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN256bfee6-3e21-4fdb-a1d0-0ef417b8be861
197770hydroCHLOROthiazide 50 MG Oral TabletPSN256bfee6-3e21-4fdb-a1d0-0ef417b8be861
310798hydrochlorothiazide 25 MG Oral TabletSCD256bfee6-3e21-4fdb-a1d0-0ef417b8be861
197770hydrochlorothiazide 50 MG Oral TabletSCD256bfee6-3e21-4fdb-a1d0-0ef417b8be861
310798HCTZ 25 MG Oral TabletSY256bfee6-3e21-4fdb-a1d0-0ef417b8be861
197770HCTZ 50 MG Oral TabletSY256bfee6-3e21-4fdb-a1d0-0ef417b8be861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-538-0021695053800100 in 1 BOTTLEHistorical
21695-538-302169505383030 in 1 BOTTLEHistorical
21695-538-602169505386060 in 1 BOTTLEHistorical
21695-538-902169505389090 in 1 BOTTLEHistorical