HYDROCHLOROTHIAZIDE

Product NDC
43353-240
11-digit product format
433530240
Labeler code
43353
Product ID
43353-240_e5f8cae3-76be-4f78-9b8a-690bacf28a09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040702
Marketing category
ANDA
Marketing start
2007-03-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040702-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16
A040702-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16
A040702-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040702-001AB
A040702-002AB
A040702-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2017-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040702-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-03-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040702-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040702-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040702-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040702-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040702-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040702-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040702-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040702-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040702-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040702-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040702-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040702-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040702-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040702-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040702-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040702-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040702-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040702-001AB11e350fbaab3a…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2febae4f-836e-4935-bd06-3495f87b3b82Available 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
43353-240-45HYDROCHLOROTHIAZIDE45 in 1 BOTTLE, PLASTICTABLET451
43353-240-60HYDROCHLOROTHIAZIDE90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-240-45EA - Each43353-240b8dac40c-382f-4e4e-a766-48f3f3b93aff12017-09-11
43353-240-60EA - Each43353-24053bdadf8-348d-4743-a6ee-69f58cb3639412017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-240HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20170817_2febae4f-836e-4935-bd06-3495f87b3b82.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEBryant Ranch Prepack03b7e52e-0003-47c3-af12-93ef00800b372026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.a85f69f5-ba97-478d-e053-2a95a90a0a972026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLC8c868894-667e-4a51-906a-838d63e420ba2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy099496f1-4e2d-8d21-e063-6294a90af6952026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf331769a-ff11-6c68-e053-2a95a90a493b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutionsf9faec8a-2b71-47bb-a296-48ecbce9af502025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.71691ccf-0ed9-4a14-8da6-7ab9b9698f522025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.93f6a018-8b3d-4f40-be25-902daec19aea2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labs4c1a92c0-b491-4ae9-8bd0-029beb2b13c62024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.1e02787f-ccb5-abc2-e063-6294a90af7c32024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.1884db5f-72b5-6b0c-e063-6394a90a0e492024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions2dd7c2a4-d335-4c6f-b1e6-b0ae6eebab842023-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP6be05675-c4b4-4e1e-9047-044a7fc7cef62021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCe8ca7334-4b58-4f4b-bf36-0ab47b60ff7c2020-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCec70ea28-a219-45d1-9d5b-6a79c7ef49872020-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC2febae4f-836e-4935-bd06-3495f87b3b822017-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040702
application number: ANDA040702
ndc (product): 43353-240

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197770hydroCHLOROthiazide 50 MG Oral TabletPSN2febae4f-836e-4935-bd06-3495f87b3b821
197770hydrochlorothiazide 50 MG Oral TabletSCD2febae4f-836e-4935-bd06-3495f87b3b821
197770HCTZ 50 MG Oral TabletSY2febae4f-836e-4935-bd06-3495f87b3b821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-240-454335302404545 TABLET in 1 BOTTLE, PLASTIC (43353-240-45) 45 tablet2016-10-040000-00-00NoNoCurrent
43353-240-604335302406090 TABLET in 1 BOTTLE, PLASTIC (43353-240-60) 90 tablet2016-05-150000-00-00NoNoCurrent