Hydrochlorothiazide

Product NDC
71610-323
11-digit product format
716100323
Labeler code
71610
Product ID
71610-323_ef422f05-e092-41df-90b0-ada79fd4f0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040907
Marketing category
ANDA
Marketing start
2009-07-02
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71610-323IInactivated by FDA2026-08-17
excluded packagepackage71610-32371610-323-45IInactivated by FDA2026-08-17
excluded packagepackage71610-32371610-323-60IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-323-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-323-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-323-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-323-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-323-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71610-323-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-323-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71610-323-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-323-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71610-323-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-323-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71610-323-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-323-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71610-323-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-323-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71610-323-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-323-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71610-323-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-323-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71610-323-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-323-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71610-323-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-323-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71610-323-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71610-323-458af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71610-323-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71610-323-45834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71610-323-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71610-323-451332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71610-323-601332a3947898…d4bfe170f9cd…

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…

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
71610-323-452023-01-30C16284748780-1f386c649-a5ac-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
71610-323-602023-01-30C16284748780-1f386c649-a5ac-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-323-45Hydrochlorothiazide45 in 1 BOTTLETABLET451
71610-323-60Hydrochlorothiazide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-323-45EA - Each71610-323d4912d1a-ba41-4453-ba5c-78df6af2cb0b12019-10-07
71610-323-60EA - Each71610-323e41203fc-93a9-4b30-8dee-fd2719a687d712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-323HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20190831_f21e4f2f-410c-44e8-8669-81f5e4200cb9.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 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
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
197770hydroCHLOROthiazide 50 MG Oral TabletPSNf21e4f2f-410c-44e8-8669-81f5e4200cb91
197770hydrochlorothiazide 50 MG Oral TabletSCDf21e4f2f-410c-44e8-8669-81f5e4200cb91
197770HCTZ 50 MG Oral TabletSYf21e4f2f-410c-44e8-8669-81f5e4200cb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-323-457161003234545 TABLET in 1 BOTTLE (71610-323-45) 45 tablet2019-08-130000-00-00NoNoCurrent
71610-323-607161003236090 TABLET in 1 BOTTLE (71610-323-60) 90 tablet2019-08-130000-00-00NoNoCurrent