FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
0172-2089
11-digit product format
001722089
Labeler code
0172
Product ID
0172-2089_6659686c-94ec-408c-b0bb-c78528aaa6c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA083177
Marketing category
ANDA
Marketing start
1980-01-07
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 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
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
0172-2089-60Hydrochlorothiazide100 in 1 BOTTLETABLET10018
0172-2089-80Hydrochlorothiazide1000 in 1 BOTTLETABLET100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-2089-00EA - Each0172-2089bac0199d-cf33-4a6a-820f-759a6decdde112012-07-24
0172-2089-10EA - Each0172-2089cc219754-a212-4a4b-b4bd-3e5150a11baa12012-07-24
0172-2089-60EA - Each0172-2089735e371a-d842-4c41-bf48-0160184a312912012-07-24
0172-2089-80EA - Each0172-2089e238c048-81e4-4231-b4ad-0f6a39bd101112012-07-24
0172-2089-85EA - Each0172-20899aeaa0bb-d3de-4372-99d1-64d81aa7271812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JHYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [IVAX PHARMACEUTICALS, INC.]10
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JHYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-2089HYDROCHLOROTHIAZIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 2 package rows20220517_e2270db4-2930-4ec5-ac96-2b4542aed367.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNe2270db4-2930-4ec5-ac96-2b4542aed36718
310798hydroCHLOROthiazide 25 MG Oral TabletPSNe2270db4-2930-4ec5-ac96-2b4542aed36718
197770hydroCHLOROthiazide 50 MG Oral TabletPSNe2270db4-2930-4ec5-ac96-2b4542aed36718
429503hydrochlorothiazide 12.5 MG Oral TabletSCDe2270db4-2930-4ec5-ac96-2b4542aed36718
310798hydrochlorothiazide 25 MG Oral TabletSCDe2270db4-2930-4ec5-ac96-2b4542aed36718
197770hydrochlorothiazide 50 MG Oral TabletSCDe2270db4-2930-4ec5-ac96-2b4542aed36718
429503HCTZ 12.5 MG Oral TabletSYe2270db4-2930-4ec5-ac96-2b4542aed36718
310798HCTZ 25 MG Oral TabletSYe2270db4-2930-4ec5-ac96-2b4542aed36718
197770HCTZ 50 MG Oral TabletSYe2270db4-2930-4ec5-ac96-2b4542aed36718
310798hydroCHLOROthiazide 25 MG Oral TabletPSN82360b40-e891-49fe-b02b-a3d8fd6659474
197770hydroCHLOROthiazide 50 MG Oral TabletPSN82360b40-e891-49fe-b02b-a3d8fd6659474
310798hydrochlorothiazide 25 MG Oral TabletSCD82360b40-e891-49fe-b02b-a3d8fd6659474
197770hydrochlorothiazide 50 MG Oral TabletSCD82360b40-e891-49fe-b02b-a3d8fd6659474
310798HCTZ 25 MG Oral TabletSY82360b40-e891-49fe-b02b-a3d8fd6659474
197770HCTZ 50 MG Oral TabletSY82360b40-e891-49fe-b02b-a3d8fd6659474
310798hydroCHLOROthiazide 25 MG Oral TabletPSN61487122-8a94-4ad5-a307-7893e0b7510c2
310798hydroCHLOROthiazide 25 MG Oral TabletPSNb5851587-d60b-4aa2-92d7-52a81dff96ab2
197770hydroCHLOROthiazide 50 MG Oral TabletPSNb5851587-d60b-4aa2-92d7-52a81dff96ab2
197770hydroCHLOROthiazide 50 MG Oral TabletPSN61487122-8a94-4ad5-a307-7893e0b7510c2
310798hydrochlorothiazide 25 MG Oral TabletSCD61487122-8a94-4ad5-a307-7893e0b7510c2
310798hydrochlorothiazide 25 MG Oral TabletSCDb5851587-d60b-4aa2-92d7-52a81dff96ab2
197770hydrochlorothiazide 50 MG Oral TabletSCD61487122-8a94-4ad5-a307-7893e0b7510c2
197770hydrochlorothiazide 50 MG Oral TabletSCDb5851587-d60b-4aa2-92d7-52a81dff96ab2
310798HCTZ 25 MG Oral TabletSY61487122-8a94-4ad5-a307-7893e0b7510c2
310798HCTZ 25 MG Oral TabletSYb5851587-d60b-4aa2-92d7-52a81dff96ab2
197770HCTZ 50 MG Oral TabletSYb5851587-d60b-4aa2-92d7-52a81dff96ab2
197770HCTZ 50 MG Oral TabletSY61487122-8a94-4ad5-a307-7893e0b7510c2
310798hydroCHLOROthiazide 25 MG Oral TabletPSNfbd5b7f2-5571-4361-af2b-4149b5f72f031
197770hydroCHLOROthiazide 50 MG Oral TabletPSNc4fe84e3-c291-4220-95c1-a2bd02b1e1341
197770hydroCHLOROthiazide 50 MG Oral TabletPSNfbd5b7f2-5571-4361-af2b-4149b5f72f031
197770hydroCHLOROthiazide 50 MG Oral TabletPSNb56a3559-6eb2-4a8d-a9a4-232d2ff0febe1
197770hydroCHLOROthiazide 50 MG Oral TabletPSNb2da16be-dd6a-4b62-b28b-a633e0235d291
310798hydrochlorothiazide 25 MG Oral TabletSCDfbd5b7f2-5571-4361-af2b-4149b5f72f031
197770hydrochlorothiazide 50 MG Oral TabletSCDb2da16be-dd6a-4b62-b28b-a633e0235d291
197770hydrochlorothiazide 50 MG Oral TabletSCDfbd5b7f2-5571-4361-af2b-4149b5f72f031
197770hydrochlorothiazide 50 MG Oral TabletSCDb56a3559-6eb2-4a8d-a9a4-232d2ff0febe1
197770hydrochlorothiazide 50 MG Oral TabletSCDc4fe84e3-c291-4220-95c1-a2bd02b1e1341
310798HCTZ 25 MG Oral TabletSYfbd5b7f2-5571-4361-af2b-4149b5f72f031
197770HCTZ 50 MG Oral TabletSYb2da16be-dd6a-4b62-b28b-a633e0235d291
197770HCTZ 50 MG Oral TabletSYc4fe84e3-c291-4220-95c1-a2bd02b1e1341
197770HCTZ 50 MG Oral TabletSYb56a3559-6eb2-4a8d-a9a4-232d2ff0febe1
197770HCTZ 50 MG Oral TabletSYfbd5b7f2-5571-4361-af2b-4149b5f72f031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0172-2089-6000172208960100 TABLET in 1 BOTTLE (0172-2089-60) 100 tablet1980-01-080000-00-00NoNoCurrent
0172-2089-80001722089801000 TABLET in 1 BOTTLE (0172-2089-80) 1000 tablet1980-01-070000-00-00NoNoCurrent