FDA.reportPublic FDA data

HydrALAZINE Hydrochloride

Product NDC
43353-205
11-digit product format
433530205
Labeler code
43353
Product ID
43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090255
Marketing category
ANDA
Marketing start
2016-05-20
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 43.

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
A090255-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-15
A090255-002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-15
A090255-003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-15
A090255-004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-15

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-1584e616aacf4f…
2026-08-18 06:07:402026-07A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090255-001HYDRALAZINE HYDROCHLORIDE10MGTABLET / ORAL2008-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090255-002HYDRALAZINE HYDROCHLORIDE25MGTABLET / ORAL2008-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090255-003HYDRALAZINE HYDROCHLORIDE50MGTABLET / ORAL2008-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090255-004HYDRALAZINE HYDROCHLORIDE100MGTABLET / ORAL2008-12-155bbf6a4d5a75…

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
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090255-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090255-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090255-003AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090255-004AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090255-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090255-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090255-003AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090255-004AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090255-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090255-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090255-003AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090255-004AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090255-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090255-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090255-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090255-004AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090255-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090255-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090255-003AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090255-004AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090255-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090255-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090255-003AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090255-004AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090255-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090255-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090255-003AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090255-004AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090255-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090255-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090255-003AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090255-004AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090255-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090255-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090255-003AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090255-004AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090255-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090255-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090255-003AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090255-004AA1c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FD171B778YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905222Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
921c8693-84c2-4313-a2a6-ab3be637d554Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-205-05HydrALAZINE Hydrochloride4200 in 1 BOTTLETABLET42001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-205-05EA - Each43353-205e97fba90-0370-4b03-a337-0c5465b7d35d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-205HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20160714_921c8693-84c2-4313-a2a6-ab3be637d554.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEExelan Pharmaceuticals Inc.811831f9-a844-463a-874d-fb8407659f0b2020-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090255
application number: ANDA090255
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090255
application number: ANDA090255
ndc (product): 43353-205

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSN921c8693-84c2-4313-a2a6-ab3be637d5541
905222hydralazine hydrochloride 100 MG Oral TabletSCD921c8693-84c2-4313-a2a6-ab3be637d5541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-205-05433530205054200 TABLET in 1 BOTTLE (43353-205-05) 4200 tablet2016-07-090000-00-00NoNoCurrent