FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
68462-341
11-digit product format
684620341
Labeler code
68462
Product ID
68462-341_b6b47424-559b-4a56-9672-6c884de6fc97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090527
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68462-341DDiscontinued by firm2026-11-06
excluded packagepackage68462-34168462-341-01DDiscontinued by firm2026-11-06
excluded packagepackage68462-34168462-341-05DDiscontinued by firm2026-11-06
excluded packagepackage68462-34168462-341-10DDiscontinued by firm2026-11-06

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-341-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1009
68462-341-05Hydralazine Hydrochloride500 in 1 BOTTLETABLET5009
68462-341-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-341-01EA - Each68462-3414f2e1a83-9765-4042-b2c0-96fa0bd26cb412012-07-24
68462-341-05EA - Each68462-3418a4996cf-1b21-4195-a75a-22f667f1da0d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-341HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]9Legacy NDC, 3 package rows20241207_37ba0233-ed75-498a-a067-6220da573653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905222hydrALAZINE HCl 100 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905225hydrALAZINE HCl 25 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905395hydrALAZINE HCl 50 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905199hydralazine hydrochloride 10 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905222hydralazine hydrochloride 100 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905225hydralazine hydrochloride 25 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905395hydralazine hydrochloride 50 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68462-341-0168462034101100 in 1 BOTTLEHistorical
68462-341-0568462034105500 in 1 BOTTLEHistorical
68462-341-10684620341101000 in 1 BOTTLEHistorical