HYDROCHLOROTHIAZIDE

Product NDC
23155-764
11-digit product format
231550764
Labeler code
23155
Product ID
23155-764_a1057270-4261-4cac-bc26-2dbffb13eacb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA085182
Marketing category
ANDA
Marketing start
2023-05-02
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
23155-764-01HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET10012
23155-764-10HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-764-01EA - Each23155-764958e91bd-ff64-402b-b600-c4b3245fea6112023-06-06
23155-764-10EA - Each23155-76435e9d2ef-7b8a-4688-ad05-fd29abcf28fa12023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-764HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, 2 package rows20230504_c59c4230-7cea-4259-9f2f-6a568716fedf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
310798hydroCHLOROthiazide 25 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
197770hydroCHLOROthiazide 50 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
429503hydrochlorothiazide 12.5 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
310798hydrochlorothiazide 25 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
197770hydrochlorothiazide 50 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
429503HCTZ 12.5 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
310798HCTZ 25 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
197770HCTZ 50 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN686a5743-adc9-4729-9dbf-5cbc2c23897a4
429503hydrochlorothiazide 12.5 MG Oral TabletSCD686a5743-adc9-4729-9dbf-5cbc2c23897a4
429503HCTZ 12.5 MG Oral TabletSY686a5743-adc9-4729-9dbf-5cbc2c23897a4
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN67c48f86-f412-4957-8e15-aec89e07d2951
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN42542233-b992-4953-87ec-5095b196d61b1
429503hydrochlorothiazide 12.5 MG Oral TabletSCD67c48f86-f412-4957-8e15-aec89e07d2951
429503hydrochlorothiazide 12.5 MG Oral TabletSCD42542233-b992-4953-87ec-5095b196d61b1
429503HCTZ 12.5 MG Oral TabletSY67c48f86-f412-4957-8e15-aec89e07d2951
429503HCTZ 12.5 MG Oral TabletSY42542233-b992-4953-87ec-5095b196d61b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-764-0123155076401100 TABLET in 1 BOTTLE (23155-764-01) 100 tablet2023-05-02NoNoCurrent
23155-764-10231550764101000 TABLET in 1 BOTTLE (23155-764-10) 1000 tablet2023-05-02NoNoCurrent