HYDROCHLOROTHIAZIDE

Product NDC
61919-580
11-digit product format
619190580
Labeler code
61919
Product ID
61919-580_f214c893-efe7-b30b-e053-2a95a90a4fb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCHLOROTHIAZIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090510
Marketing category
ANDA
Marketing start
2019-08-21
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-580IInactivated by FDA2026-08-17
excluded productproduct61919-580IInactivated by FDA2026-08-17
excluded packagepackage61919-58061919-580-30IInactivated by FDA2026-08-17
excluded packagepackage61919-58061919-580-71IInactivated by FDA2026-08-17
excluded packagepackage61919-58061919-580-90IInactivated 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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-580-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-580-71IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-580-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-580-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-580-71IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-580-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-580-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-580-71IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-580-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-580-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-580-71IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-580-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-580-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-580-71IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-580-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-580-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-580-71IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-580-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-580-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-580-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-580-71IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-580-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-580-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-580-71IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-580-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-580-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-580-71IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-580-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-580-71IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-580-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-580-71IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-580-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-580-71IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-580-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-580-71IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-580-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-580-71IInactivated by FDA834df4deac94…adcc014656a3…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090510-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090510-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090510-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090510-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090510-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090510-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090510-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090510-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090510-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090510-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090510-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090510-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090510-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090510-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090510-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090510-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090510-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090510-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090510-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090510-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090510-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090510-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090510-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090510-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090510-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090510-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090510-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090510-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090510-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090510-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090510-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090510-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090510-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090510-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090510-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090510-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090510-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090510-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090510-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090510-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090510-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090510-001AB1e64feba35796…

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
61919-580-902025-01-30C16284748780-12cef2736-8f95-d83d-e063-dadaa90ab31fHYDROCHLOROTHIAZIDE
61919-580-302020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE
61919-580-712020-01-31C16284748780-19d75b9d0-35ad-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-580-30HYDROCHLOROTHIAZIDE30 in 1 BOTTLECAPSULE304
61919-580-71HYDROCHLOROTHIAZIDE100 in 1 BOTTLECAPSULE1004
61919-580-90HYDROCHLOROTHIAZIDE90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-580-30EA - Each61919-5803eb530af-f45c-40c2-9e31-59619685aa8712015-03-03
61919-580-71EA - Each61919-5804b40713b-fce9-4b1c-a316-9af5b6b95a4712015-11-12
61919-580-90EA - Each61919-580dca9282c-17ce-48b7-8329-2f3765947f0e12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT RX]4Legacy NDC, 2 package rows20161020_b0f2e5c7-2135-4154-bde7-9080e95d3e91.zip
61919-580HYDROCHLOROTHIAZIDE CAPSULE [DIRECT_RX]4Legacy NDC, 1 package rows20230113_90a0a64c-1c98-f27b-e053-2a95a90a8ca5.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCe3afa83d-c79c-848a-e053-2a95a90ac9222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma Inc578f74ea-53d1-4c44-b872-66033292abe02025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging13ed002f-c5bb-401c-891a-70b70cbd8fb62025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQuality Care Products LLCa2de8e26-ef5a-41c7-888b-990629b111452024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack6a11a458-dc69-40ba-a58a-649733e0e8ab2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP98edae8a-99dc-4f26-a956-3ad58bf38a262022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDb0f2e5c7-2135-4154-bde7-9080e95d3e914
199903HCTZ 12.5 MG Oral CapsuleSY90a0a64c-1c98-f27b-e053-2a95a90a8ca54
199903HCTZ 12.5 MG Oral CapsuleSYb0f2e5c7-2135-4154-bde7-9080e95d3e914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-580-306191905803030 in 1 BOTTLEHistorical
61919-580-7161919058071100 in 1 BOTTLEHistorical
61919-580-906191905809090 CAPSULE in 1 BOTTLE (61919-580-90) 90 capsule2019-08-210000-00-00NoNoCurrent