Hydrochlorothiazide

Product NDC
60687-894
11-digit product format
606870894
Labeler code
60687
Product ID
60687-894_4c4890b6-96dc-0848-e063-6394a90a125b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040907
Marketing category
ANDA
Marketing start
2026-03-01
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A040907-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15
A040907-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15
A040907-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040907-001AB
A040907-002AB
A040907-003AB

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 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-154b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040907-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040907-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040907-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040907-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040907-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040907-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040907-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040907-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040907-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040907-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040907-002AB14b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 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
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
2ec371a5-18ba-4ce2-9725-7f99bb73454aAvailable 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
60687-894-01Hydrochlorothiazide100 in 1 CARTONTABLET1001
60687-894-11Hydrochlorothiazide1 in 1 BLISTER PACKTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-894-01EA - Each60687-8941b328fdc-5a7a-4040-bdf4-f250890fd57112026-04-20
60687-894-11EA - Each60687-894e58d1d3d-98b6-4f4a-969e-6c4e5083026212026-04-20

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy8a1de4e2-3aca-a4d3-e053-2995a90a1a412026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.99f45e08-897d-44dd-b48d-aa6d78981f0c2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.2fd8f595-7aec-4308-bb17-a6f2e71900442026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDECoupler LLC4ee35bcf-1eb0-1cca-e063-6294a90adeed2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging2ec371a5-18ba-4ce2-9725-7f99bb73454a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
ndc (product): 60687-894
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions088cb67f-3eaa-4e78-9fbe-ad2d6b7c57072026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsf1f99065-04d2-48ac-b25d-9595237c869c2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2f3b60a-bffe-2675-e053-2995a90ae96e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.9cd5d16e-3db7-4b25-847d-6de91543463b2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.67bedecc-f758-4bc6-82c5-7d428cbbbd9b2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackd7d0867a-748e-4960-851f-ad764e07f7742025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack73bc116a-2964-4acc-9ef0-0a3f662689132025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.33f3b980-b339-4dbf-99bd-05588c2a298c2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm drugfa1c0b92-4360-bcfd-e053-6394a90a955a2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEDirect_Rx05156717-fe1b-22f1-e063-6394a90a3d102025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLC9e6a0c83-1494-44ca-90e0-3f43fa8ec7462024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.8bc8d5e2-a974-64ed-e053-2a95a90a83402024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPff448eb4-b48f-46f5-ac30-f03aad08f9f52024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN2ec371a5-18ba-4ce2-9725-7f99bb73454a1
310798hydrochlorothiazide 25 MG Oral TabletSCD2ec371a5-18ba-4ce2-9725-7f99bb73454a1
310798HCTZ 25 MG Oral TabletSY2ec371a5-18ba-4ce2-9725-7f99bb73454a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-894-0160687089401100 BLISTER PACK in 1 CARTON (60687-894-01) / 1 TABLET in 1 BLISTER PACK (60687-894-11) 100 blister pack2026-03-01NoNoCurrent
60687-894-11606870894111 in 1 BLISTER PACKHistorical