Hydrochlorothiazide

Product NDC
57237-002
11-digit product format
572370002
Labeler code
57237
Product ID
57237-002_adc31708-42a5-4529-ab66-b0445d1ba5e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078164
Marketing category
ANDA
Marketing start
2007-09-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078164-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078164-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078164-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078164-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078164-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078164-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078164-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078164-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078164-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078164-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078164-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078164-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078164-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078164-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078164-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078164-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078164-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078164-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078164-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078164-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078164-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078164-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078164-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078164-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078164-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078164-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078164-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078164-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078164-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078164-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078164-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078164-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078164-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078164-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078164-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078164-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078164-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078164-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078164-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078164-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078164-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078164-001AB1e64feba35796…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199903Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33f9c3ae-108d-469e-af6c-8be3b0f83139Available on FDA.report

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
57237-002-01Hydrochlorothiazide100 in 1 BOTTLECAPSULE1009
57237-002-05Hydrochlorothiazide500 in 1 BOTTLECAPSULE5009
57237-002-99Hydrochlorothiazide1000 in 1 BOTTLECAPSULE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-002-01EA - Each57237-0023888b572-953a-4be3-9502-6dcfd131225e12013-10-17
57237-002-05EA - Each57237-0028931442d-1e5d-43d1-8e4e-b766f4fae61212015-01-05
57237-002-99EA - Each57237-002a8dfce4e-bea6-4bbf-8023-e0dd918aba7112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
SHELLACINACTIVE INGREDIENT46N107B71OHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [CITRON PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-002HYDROCHLOROTHIAZIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 3 package rows20240924_33f9c3ae-108d-469e-af6c-8be3b0f83139.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b02025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack8242c1de-f482-4a85-b977-610e71fa49042024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
HydrochlorothiazideHYDROCHLOROTHIAZIDERising Pharma Holdings, Inc.33f9c3ae-108d-469e-af6c-8be3b0f831392024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
ndc (product): 57237-002
HydrochlorothiazideHYDROCHLOROTHIAZIDEAurobindo Pharma Limitede31bd548-29ae-419a-831a-80ebb26e042f2024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN33f9c3ae-108d-469e-af6c-8be3b0f831399
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN8242c1de-f482-4a85-b977-610e71fa49049
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD33f9c3ae-108d-469e-af6c-8be3b0f831399
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD8242c1de-f482-4a85-b977-610e71fa49049
199903HCTZ 12.5 MG Oral CapsuleSY33f9c3ae-108d-469e-af6c-8be3b0f831399
199903HCTZ 12.5 MG Oral CapsuleSY8242c1de-f482-4a85-b977-610e71fa49049
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b01
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b01
199903HCTZ 12.5 MG Oral CapsuleSY82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-002-0157237000201100 CAPSULE in 1 BOTTLE (57237-002-01) 100 capsule2007-09-190000-00-00NoNoCurrent
57237-002-0557237000205500 CAPSULE in 1 BOTTLE (57237-002-05) 500 capsule2007-09-190000-00-00NoNoCurrent
57237-002-99572370002991000 CAPSULE in 1 BOTTLE (57237-002-99) 1000 capsule2007-09-190000-00-00NoNoCurrent