FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
16729-184
11-digit product format
167290184
Labeler code
16729
Product ID
16729-184_4e6be915-b8a1-bef8-e063-6394a90a324c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202556
Marketing category
ANDA
Marketing start
2013-04-10
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 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
HYDROCHLOROTHIAZIDE50 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
16729-184-01Hydrochlorothiazide100 in 1 BOTTLETABLET1006
16729-184-17Hydrochlorothiazide1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-184-01EA - Each16729-184aef26e13-25eb-420b-8985-4a405bdcf9a412013-05-02
16729-184-17EA - Each16729-184c244c7ce-9d25-4bd2-99ea-3d6bc4de85b312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-184HYDROCHLOROTHIAZIDE TABLET [ACCORD HEALTHCARE INC.]3Current NDC, Legacy NDC, 2 package rows20200902_babb1b20-fe82-40ba-8e7a-0c56fe433b4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
310798hydroCHLOROthiazide 25 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
197770hydroCHLOROthiazide 50 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
429503hydrochlorothiazide 12.5 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
310798hydrochlorothiazide 25 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
197770hydrochlorothiazide 50 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
429503HCTZ 12.5 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
310798HCTZ 25 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
197770HCTZ 50 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
197770hydroCHLOROthiazide 50 MG Oral TabletPSN27a7e751-8aca-440e-95e4-cfecae1a246512
197770hydrochlorothiazide 50 MG Oral TabletSCD27a7e751-8aca-440e-95e4-cfecae1a246512
197770HCTZ 50 MG Oral TabletSY27a7e751-8aca-440e-95e4-cfecae1a246512
197770hydroCHLOROthiazide 50 MG Oral TabletPSNa013211e-b8f8-426d-8e55-e86193f0634e9
197770hydrochlorothiazide 50 MG Oral TabletSCDa013211e-b8f8-426d-8e55-e86193f0634e9
197770HCTZ 50 MG Oral TabletSYa013211e-b8f8-426d-8e55-e86193f0634e9
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798hydroCHLOROthiazide 25 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770hydroCHLOROthiazide 50 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
429503hydrochlorothiazide 12.5 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798hydrochlorothiazide 25 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770hydrochlorothiazide 50 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
429503HCTZ 12.5 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798HCTZ 25 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770HCTZ 50 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770hydroCHLOROthiazide 50 MG Oral TabletPSN53fe1730-a803-26b2-e054-00144ff88e885
197770hydroCHLOROthiazide 50 MG Oral TabletPSN48b4d633-ecfa-4748-80e8-6c0e3d8b067e5
197770hydrochlorothiazide 50 MG Oral TabletSCD53fe1730-a803-26b2-e054-00144ff88e885
197770hydrochlorothiazide 50 MG Oral TabletSCD48b4d633-ecfa-4748-80e8-6c0e3d8b067e5
197770HCTZ 50 MG Oral TabletSY53fe1730-a803-26b2-e054-00144ff88e885
197770HCTZ 50 MG Oral TabletSY48b4d633-ecfa-4748-80e8-6c0e3d8b067e5
197770hydroCHLOROthiazide 50 MG Oral TabletPSNab8115a0-e96f-7aee-e053-2995a90a6ec04
197770hydrochlorothiazide 50 MG Oral TabletSCDab8115a0-e96f-7aee-e053-2995a90a6ec04
197770HCTZ 50 MG Oral TabletSYab8115a0-e96f-7aee-e053-2995a90a6ec04
197770hydroCHLOROthiazide 50 MG Oral TabletPSN526af013-5fd5-5f4c-e054-00144ff88e883
197770hydrochlorothiazide 50 MG Oral TabletSCD526af013-5fd5-5f4c-e054-00144ff88e883
197770HCTZ 50 MG Oral TabletSY526af013-5fd5-5f4c-e054-00144ff88e883
197770hydroCHLOROthiazide 50 MG Oral TabletPSNc2d993ff-b11b-7a62-e053-2995a90a0b002
197770hydroCHLOROthiazide 50 MG Oral TabletPSNcbe5e01e-67ca-f8a2-e053-2995a90a0d152
197770hydroCHLOROthiazide 50 MG Oral TabletPSNd43a95f0-b987-78a3-e053-2a95a90a80752
197770hydrochlorothiazide 50 MG Oral TabletSCDc2d993ff-b11b-7a62-e053-2995a90a0b002
197770hydrochlorothiazide 50 MG Oral TabletSCDcbe5e01e-67ca-f8a2-e053-2995a90a0d152
197770hydrochlorothiazide 50 MG Oral TabletSCDd43a95f0-b987-78a3-e053-2a95a90a80752
197770HCTZ 50 MG Oral TabletSYc2d993ff-b11b-7a62-e053-2995a90a0b002
197770HCTZ 50 MG Oral TabletSYcbe5e01e-67ca-f8a2-e053-2995a90a0d152
197770HCTZ 50 MG Oral TabletSYd43a95f0-b987-78a3-e053-2a95a90a80752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-184-0116729018401100 TABLET in 1 BOTTLE (16729-184-01) 100 tablet2013-04-260000-00-00NoNoCurrent
16729-184-17167290184171000 TABLET in 1 BOTTLE (16729-184-17) 1000 tablet2013-04-100000-00-00NoNoCurrent