FDA.reportPublic FDA data

hydrALAZINE Hydrochloride

Product NDC
63323-614
11-digit product format
633230614
Labeler code
63323
Product ID
63323-614_2f8362b3-0a39-40b0-95bf-4a786cb15a74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrALAZINE Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA040388
Marketing category
ANDA
Marketing start
2011-01-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui966571

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
63323-614-16Hydralazine Hydrochloride25 in 1 TRAYINJECTION2512
63323-614-41Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-USEINJECTION112
63323-614-00Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
63323-614-01Hydralazine Hydrochloride25 in 1 CARTONINJECTION256
63323-614-21hydrALAZINE Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION15
63323-614-55hydrALAZINE Hydrochloride25 in 1 TRAYINJECTION255
63323-614-03Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
63323-614-06Hydralazine Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-614-00ML - Milliliter63323-614e805ab0a-5d3c-47ca-b6a9-f259bd0be77e12018-07-03
63323-614-01ML - Milliliter63323-61424c76541-8711-454d-8045-1541be109d8112012-07-24
63323-614-03ML - Milliliter63323-614620b9d9f-07d6-4935-a12f-a4751e30a7de12026-02-05
63323-614-06ML - Milliliter63323-614368da241-e5a9-4520-9f87-ff9fb0bb381b12026-02-05
63323-614-16ML - Milliliter63323-614032b94ea-0e8e-41ca-b85d-63c0d5229fd212015-10-02
63323-614-21ML - Milliliter63323-614b91eda93-e4f2-4235-a120-aa7e57e8352912024-03-12
63323-614-41ML - Milliliter63323-614a31640cb-3fc6-40af-9b1c-c1b4850df42812024-04-05
63323-614-55ML - Milliliter63323-6144731af4b-bba4-440b-8a07-b942a4bcabe412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]10
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-614HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 2 package rows20220604_8223c44a-73a9-4da5-a468-d1d8bdb0bbd6.zip
63323-614HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20220419_f34904dc-c945-4de4-8594-34e4f4ac1983.zip
63323-614HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20220820_c3797028-c625-4f70-ae69-8a5f6f23f1b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN8223c44a-73a9-4da5-a468-d1d8bdb0bbd612
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD8223c44a-73a9-4da5-a468-d1d8bdb0bbd612
966571hydralazine HCl 20 MG per 1 ML InjectionSY8223c44a-73a9-4da5-a468-d1d8bdb0bbd612
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN43ce0ecb-6d62-44bf-8539-823ae03eb9f49
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD43ce0ecb-6d62-44bf-8539-823ae03eb9f49
966571hydralazine HCl 20 MG per 1 ML InjectionSY43ce0ecb-6d62-44bf-8539-823ae03eb9f49
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN9949407f-e410-7f47-e053-2995a90a73696
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNf34904dc-c945-4de4-8594-34e4f4ac19836
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDf34904dc-c945-4de4-8594-34e4f4ac19836
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD9949407f-e410-7f47-e053-2995a90a73696
966571hydralazine HCl 20 MG per 1 ML InjectionSYf34904dc-c945-4de4-8594-34e4f4ac19836
966571hydralazine HCl 20 MG per 1 ML InjectionSY9949407f-e410-7f47-e053-2995a90a73696
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNc3797028-c625-4f70-ae69-8a5f6f23f1b85
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDc3797028-c625-4f70-ae69-8a5f6f23f1b85
966571hydralazine HCl 20 MG per 1 ML InjectionSYc3797028-c625-4f70-ae69-8a5f6f23f1b85
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNc5647a72-22da-420a-a549-7b5185a621d44
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDc5647a72-22da-420a-a549-7b5185a621d44
966571hydralazine HCl 20 MG per 1 ML InjectionSYc5647a72-22da-420a-a549-7b5185a621d44
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN7979c865-737d-d999-e053-2a91aa0abc5e3
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNdca82025-a4cd-4856-aa19-bdf091bf89733
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD7979c865-737d-d999-e053-2a91aa0abc5e3
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDdca82025-a4cd-4856-aa19-bdf091bf89733
966571hydralazine HCl 20 MG per 1 ML InjectionSY7979c865-737d-d999-e053-2a91aa0abc5e3
966571hydralazine HCl 20 MG per 1 ML InjectionSYdca82025-a4cd-4856-aa19-bdf091bf89733
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN3855c3da-ff25-8301-e063-6294a90a22b32
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN8b7e88ef-5edd-40df-8e43-e3f29970be582
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNdd2cd8a1-7bdd-05e4-e053-2995a90ad3662
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN4d1f55aa-e924-4540-ae9f-bd7362a82f332
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD8b7e88ef-5edd-40df-8e43-e3f29970be582
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD3855c3da-ff25-8301-e063-6294a90a22b32
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD4d1f55aa-e924-4540-ae9f-bd7362a82f332
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDdd2cd8a1-7bdd-05e4-e053-2995a90ad3662
966571hydralazine HCl 20 MG per 1 ML InjectionSYdd2cd8a1-7bdd-05e4-e053-2995a90ad3662
966571hydralazine HCl 20 MG per 1 ML InjectionSY3855c3da-ff25-8301-e063-6294a90a22b32
966571hydralazine HCl 20 MG per 1 ML InjectionSY8b7e88ef-5edd-40df-8e43-e3f29970be582
966571hydralazine HCl 20 MG per 1 ML InjectionSY4d1f55aa-e924-4540-ae9f-bd7362a82f332
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNbf1b7c2f-535c-45bb-928a-65606d87685e1
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDbf1b7c2f-535c-45bb-928a-65606d87685e1
966571hydralazine HCl 20 MG per 1 ML InjectionSYbf1b7c2f-535c-45bb-928a-65606d87685e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-614-00633230614001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-614-016332306140125 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-00) 2001-09-050000-00-00NoNoCurrent
63323-614-03633230614031 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-614-066332306140625 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-06) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-03) 2001-09-05NoNoHistorical
63323-614-166332306141625 VIAL, SINGLE-USE in 1 TRAY (63323-614-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-614-41) 2001-09-050000-00-00NoNoCurrent
63323-614-21633230614211 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-614-41633230614411 mL in 1 VIAL, SINGLE-USE1 mlHistorical
63323-614-556332306145525 VIAL, SINGLE-DOSE in 1 TRAY (63323-614-55) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-21) 2011-01-310000-00-00NoNoCurrent