Hydrochlorothiazide

Product NDC
0591-0347
11-digit product format
005910347
Labeler code
0591
Product ID
0591-0347_b062bc7e-af92-4648-aed1-e02568313e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA020504
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-12-27
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
Rxcui199903

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
0591-0347-01Hydrochlorothiazide100 in 1 BOTTLECAPSULE, GELATIN COATED10024
0591-0347-05Hydrochlorothiazide500 in 1 BOTTLECAPSULE, GELATIN COATED50024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0347-01EA - Each0591-0347c9282ce9-22fd-4fa7-81cf-de180d8770f412012-07-24
0591-0347-05EA - Each0591-03471a2d2b20-68f7-4659-b5bf-f697687ef4db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0347HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 2 package rows20240509_a3eb7294-f913-434b-896c-da028bfebc73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNa3eb7294-f913-434b-896c-da028bfebc7324
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDa3eb7294-f913-434b-896c-da028bfebc7324
199903HCTZ 12.5 MG Oral CapsuleSYa3eb7294-f913-434b-896c-da028bfebc7324
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903HCTZ 12.5 MG Oral CapsuleSY5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNc1052d38-fd75-40c2-a685-0e889009be0b6
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDc1052d38-fd75-40c2-a685-0e889009be0b6
199903HCTZ 12.5 MG Oral CapsuleSYc1052d38-fd75-40c2-a685-0e889009be0b6
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN118f7c88-dd50-25d5-e054-00144ff88e881
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN1576a4be-c3ec-426e-9219-c6a0c99f294f1
310798hydroCHLOROthiazide 25 MG Oral TabletPSN118f7c88-dd6e-25d5-e054-00144ff88e881
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD1576a4be-c3ec-426e-9219-c6a0c99f294f1
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD118f7c88-dd50-25d5-e054-00144ff88e881
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
310798hydrochlorothiazide 25 MG Oral TabletSCD118f7c88-dd6e-25d5-e054-00144ff88e881
199903HCTZ 12.5 MG Oral CapsuleSY0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
199903HCTZ 12.5 MG Oral CapsuleSY1576a4be-c3ec-426e-9219-c6a0c99f294f1
199903HCTZ 12.5 MG Oral CapsuleSY118f7c88-dd50-25d5-e054-00144ff88e881
310798HCTZ 25 MG Oral TabletSY118f7c88-dd6e-25d5-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0347-000059103470028085 CAPSULE, GELATIN COATED in 1 BOX (0591-0347-00)27-DEC-96Current
0591-0347-0100591034701100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01) 1996-12-270000-00-00NoNoCurrent
0591-0347-0500591034705500 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-05) 1996-12-270000-00-00NoNoCurrent
0591-0347-770059103477728085 CAPSULE, GELATIN COATED in 1 CONTAINER (0591-0347-77)01-AUG-24Current