Hydrochlorothiazide

Product NDC
59746-382
11-digit product format
597460382
Labeler code
59746
Product ID
59746-382_69ecf531-05af-4750-a9df-fec6ee7e3a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS INC.
Application
ANDA078391
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-382-06EA - Each59746-3822621f4af-3e81-465b-9e94-0be056c1bef812012-07-24
59746-382-10EA - Each59746-3827ba84cc9-0852-4dc4-ba83-860b363054a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Fd&c Blue No. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
ShellacINACTIVE INGREDIENT46N107B71OHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-382HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3Legacy NDC20211221_eda91d6d-3a53-5125-5bb5-b5a72276af39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN436e7821-d0b6-4476-8ff1-f5c1dfd2d7255
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD436e7821-d0b6-4476-8ff1-f5c1dfd2d7255
199903HCTZ 12.5 MG Oral CapsuleSY436e7821-d0b6-4476-8ff1-f5c1dfd2d7255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-382-055974603820530 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-382-05) 2008-02-110000-00-00NoNoCurrent
59746-382-0659746038206100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-382-06) 2008-02-110000-00-00NoNoCurrent
59746-382-10597460382101000 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-382-10) 2008-02-110000-00-00NoNoCurrent