Hydralazine Hydrochloride

Product NDC
53808-0882
11-digit product format
538080882
Labeler code
53808
Product ID
53808-0882_104c0170-6b56-415e-90b4-85f777ba2792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA090527
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0882IInactivated by FDA2026-11-06
excluded packagepackage53808-088253808-0882-2IInactivated by FDA2026-11-06

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 · 42 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 packagepackage53808-0882-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0882-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0882-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0882-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0882-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0882-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0882-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0882-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0882-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0882-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0882-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0882-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0882-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0882-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0882-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0882-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0882-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0882-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0882-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0882-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0882-29bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090527-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29
A090527-002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29
A090527-003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29
A090527-004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090527-001AA
A090527-002AA
A090527-003AA
A090527-004AA

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29c2088c7a36db…
2026-10-15 13:18:302026-09A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29c2088c7a36db…
2026-10-15 13:18:302026-09A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29c2088c7a36db…
2026-10-15 13:18:302026-09A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29c2088c7a36db…
2026-09-14 22:38:342026-08A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORALAA2009-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORALAA2009-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORALAA2009-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORALAA2009-05-292680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090527-001AA1c2088c7a36db…
2026-10-15 13:18:302026-09A090527-002AA1c2088c7a36db…
2026-10-15 13:18:302026-09A090527-003AA1c2088c7a36db…
2026-10-15 13:18:302026-09A090527-004AA1c2088c7a36db…
2026-09-14 22:38:342026-08A090527-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A090527-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A090527-003AA184e616aacf4f…
2026-09-14 22:38:342026-08A090527-004AA184e616aacf4f…
2026-08-18 06:07:402026-07A090527-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090527-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090527-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090527-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090527-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090527-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090527-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090527-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090527-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090527-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090527-004AA12680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0882-22020-01-31C16284748780-19d75b9d1-2ab1-f424-e053-dadaa90a57ceHydralazine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0882-2Hydralazine Hydrochloride60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0882HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_0a07b11f-dfad-4976-b979-287d7a681e69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN0a07b11f-dfad-4976-b979-287d7a681e691
905395hydralazine hydrochloride 50 MG Oral TabletSCD0a07b11f-dfad-4976-b979-287d7a681e691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0882-25380808820260 in 1 BLISTER PACKHistorical