Hydrochlorothiazide

Product NDC
43547-398
11-digit product format
435470398
Labeler code
43547
Product ID
43547-398_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA040412
Marketing category
ANDA
Marketing start
2002-03-29
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040412-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29
A040412-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040412-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040412-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040412-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040412-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040412-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040412-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040412-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040412-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040412-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040412-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040412-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040412-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040412-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040412-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040412-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040412-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040412-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040412-002AB1ea1830bbd6c7…

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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197770Internal RxNorm lookup
310798Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60c97ab9-b25e-4ea5-a159-792292178c65Available 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
43547-398-01Hydrochlorothiazide10 in 1 BOTTLE, PLASTICTABLET102
43547-398-03Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET302
43547-398-05Hydrochlorothiazide50 in 1 BOTTLE, PLASTICTABLET502
43547-398-10Hydrochlorothiazide100 in 1 BOTTLE, PLASTICTABLET1002
43547-398-11Hydrochlorothiazide1000 in 1 BOTTLE, PLASTICTABLET10002
43547-398-50Hydrochlorothiazide500 in 1 BOTTLE, PLASTICTABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-398-10EA - Each43547-398c96b89be-b3fb-4fb1-9c6e-4962e14be4d312017-05-03
43547-398-11EA - Each43547-3985ea3eb5e-c4df-4a4c-ae30-864de26c932112017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-398HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE U.S., LLC]2Current NDC, Legacy NDC, 6 package rows20200915_60c97ab9-b25e-4ea5-a159-792292178c65.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 43547-398

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197770hydroCHLOROthiazide 50 MG Oral TabletPSN24cba606-263f-46dc-a4dc-fddc729c0f4b102
197770hydrochlorothiazide 50 MG Oral TabletSCD24cba606-263f-46dc-a4dc-fddc729c0f4b102
197770HCTZ 50 MG Oral TabletSY24cba606-263f-46dc-a4dc-fddc729c0f4b102
197770hydroCHLOROthiazide 50 MG Oral TabletPSN78d65a02-c78e-4f98-b756-3cb5ee78f252101
197770hydrochlorothiazide 50 MG Oral TabletSCD78d65a02-c78e-4f98-b756-3cb5ee78f252101
197770HCTZ 50 MG Oral TabletSY78d65a02-c78e-4f98-b756-3cb5ee78f252101
197770hydroCHLOROthiazide 50 MG Oral TabletPSN4c3403a6-da6a-4f37-bc7e-9fe0aa284305100
197770hydrochlorothiazide 50 MG Oral TabletSCD4c3403a6-da6a-4f37-bc7e-9fe0aa284305100
197770HCTZ 50 MG Oral TabletSY4c3403a6-da6a-4f37-bc7e-9fe0aa284305100
310798hydroCHLOROthiazide 25 MG Oral TabletPSN0fdb6713-8013-4cfe-a776-0c1e9414a91c4
197770hydroCHLOROthiazide 50 MG Oral TabletPSN0fdb6713-8013-4cfe-a776-0c1e9414a91c4
310798hydrochlorothiazide 25 MG Oral TabletSCD0fdb6713-8013-4cfe-a776-0c1e9414a91c4
197770hydrochlorothiazide 50 MG Oral TabletSCD0fdb6713-8013-4cfe-a776-0c1e9414a91c4
310798HCTZ 25 MG Oral TabletSY0fdb6713-8013-4cfe-a776-0c1e9414a91c4
197770HCTZ 50 MG Oral TabletSY0fdb6713-8013-4cfe-a776-0c1e9414a91c4
310798hydroCHLOROthiazide 25 MG Oral TabletPSN60c97ab9-b25e-4ea5-a159-792292178c652
197770hydroCHLOROthiazide 50 MG Oral TabletPSN60c97ab9-b25e-4ea5-a159-792292178c652
197770hydroCHLOROthiazide 50 MG Oral TabletPSNf3d2d017-e6a0-4823-e053-2995a90a57642
310798hydrochlorothiazide 25 MG Oral TabletSCD60c97ab9-b25e-4ea5-a159-792292178c652
197770hydrochlorothiazide 50 MG Oral TabletSCD60c97ab9-b25e-4ea5-a159-792292178c652
197770hydrochlorothiazide 50 MG Oral TabletSCDf3d2d017-e6a0-4823-e053-2995a90a57642
310798HCTZ 25 MG Oral TabletSY60c97ab9-b25e-4ea5-a159-792292178c652
197770HCTZ 50 MG Oral TabletSY60c97ab9-b25e-4ea5-a159-792292178c652
197770HCTZ 50 MG Oral TabletSYf3d2d017-e6a0-4823-e053-2995a90a57642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-398-014354703980110 TABLET in 1 BOTTLE, PLASTIC (43547-398-01) 10 tablet2002-03-290000-00-00NoNoCurrent
43547-398-034354703980330 TABLET in 1 BOTTLE, PLASTIC (43547-398-03) 30 tablet2002-03-290000-00-00NoNoCurrent
43547-398-054354703980550 TABLET in 1 BOTTLE, PLASTIC (43547-398-05) 50 tablet2002-03-290000-00-00NoNoCurrent
43547-398-1043547039810100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10) 100 tablet2002-03-290000-00-00NoNoCurrent
43547-398-11435470398111000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11) 1000 tablet2002-03-290000-00-00NoNoCurrent
43547-398-5043547039850500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50) 500 tablet2002-03-290000-00-00NoNoCurrent