Hydrochlorothiazide

Product NDC
68071-5211
11-digit product format
680715211
Labeler code
68071
Product ID
68071-5211_1b57747f-6805-839f-e063-6294a90a860f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA085182
Marketing category
ANDA
Marketing start
2015-01-15
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 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 1.

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
A085182-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982
A085182-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982
A085182-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085182-001AB
A085182-002AB
A085182-003AB

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 · 104 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085182-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085182-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085182-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085182-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2026-12-31

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
a111cb8f-a100-a05d-e053-2995a90a020cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5211-22022-02-07C16284748780-1d6a99b39-d50e-a426-e053-dadaa90af4c2HYDROCHLOROTHIAZIDE TABLETS, USP Rx only
68071-5211-22022-01-28C16284748780-1d6a99b39-d50e-a426-e053-dadaa90af4c2HYDROCHLOROTHIAZIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5211-2Hydrochlorothiazide120 in 1 BOTTLETABLET1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5211HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a111cb8f-a100-a05d-e053-2995a90a020c.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.686a5743-adc9-4729-9dbf-5cbc2c23897a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLCc8c79657-a09a-bdb6-e053-2995a90ab6732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLC076017ce-8aad-1336-e063-6394a90a76b52025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDEChartwell RX, LLC4e43dd27-3f4b-4205-a26e-6ecaa82813472025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEQPharma Incf795db5e-d5ef-4a20-e053-6394a90a7fda2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1fad059f-f030-4dd8-b02a-bf3e775d37d22025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions67c48f86-f412-4957-8e15-aec89e07d2952025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions42542233-b992-4953-87ec-5095b196d61b2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.c59c4230-7cea-4259-9f2f-6a568716fedf2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.a111cb8f-a100-a05d-e053-2995a90a020c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
ndc (product): 68071-5211
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labs5605f105-f7ec-473f-8beb-9e8955e8e26e2023-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEProficient Rx LP3464be28-5bab-4642-9d9b-8b425822dd072023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSNa111cb8f-a100-a05d-e053-2995a90a020c3
310798hydrochlorothiazide 25 MG Oral TabletSCDa111cb8f-a100-a05d-e053-2995a90a020c3
310798HCTZ 25 MG Oral TabletSYa111cb8f-a100-a05d-e053-2995a90a020c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5211-268071521102120 TABLET in 1 BOTTLE (68071-5211-2) 120 tablet2020-03-170000-00-00NoNoCurrent