NDC 63323-614-03 - hydrALAZINE Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63323-614
Requested NDC: 63323-614-03
Package NDCs from labels: 63323-614-03, 63323-614-06, 63323-614-00, 63323-614-01, 63323-614-21, 63323-614-55, 63323-614-41, 63323-614-16
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-08-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
hydrALAZINE Hydrochloride Injection, USP	REMEDYREPACK INC.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2025-11-28	HUMAN PRESCRIPTION DRUG LABEL
hydrALAZINE Hydrochloride - ProPharma Distribution	ProPharma Distribution	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride Injection, USP	Henry Schein, Inc.	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL
HYDRALAZINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-02	HUMAN PRESCRIPTION DRUG LABEL
hydrALAZINE Hydrochloride - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2022-08-09	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2022-05-18	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2021-04-15	Human Prescription Drug Label
Hydralazine Hydrochloride - Cardinal Health	Cardinal Health	2020-07-10	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - General Injectables & Vaccines, Inc	General Injectables & Vaccines, Inc	2019-12-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-614-16	Hydralazine Hydrochloride	25 in 1 TRAY	INJECTION	25	12
63323-614-41	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-USE	INJECTION	1	12
63323-614-00	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	6
63323-614-01	Hydralazine Hydrochloride	25 in 1 CARTON	INJECTION	25	6
63323-614-21	hydrALAZINE Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	5
63323-614-55	hydrALAZINE Hydrochloride	25 in 1 TRAY	INJECTION	25	5
63323-614-03	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	1
63323-614-06	Hydralazine Hydrochloride	25 in 1 CARTON	INJECTION	25	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	12	Current NDC, Legacy NDC, 2 package rows	20220604_8223c44a-73a9-4da5-a468-d1d8bdb0bbd6.zip
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220419_f34904dc-c945-4de4-8594-34e4f4ac1983.zip
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220820_c3797028-c625-4f70-ae69-8a5f6f23f1b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-614-00	ML - Milliliter	63323-614	e805ab0a-5d3c-47ca-b6a9-f259bd0be77e	1	2018-07-03
63323-614-01	ML - Milliliter	63323-614	24c76541-8711-454d-8045-1541be109d81	1	2012-07-24
63323-614-03	ML - Milliliter	63323-614	620b9d9f-07d6-4935-a12f-a4751e30a7de	1	2026-02-05
63323-614-06	ML - Milliliter	63323-614	368da241-e5a9-4520-9f87-ff9fb0bb381b	1	2026-02-05
63323-614-16	ML - Milliliter	63323-614	032b94ea-0e8e-41ca-b85d-63c0d5229fd2	1	2015-10-02
63323-614-21	ML - Milliliter	63323-614	b91eda93-e4f2-4235-a120-aa7e57e83529	1	2024-03-12
63323-614-41	ML - Milliliter	63323-614	a31640cb-3fc6-40af-9b1c-c1b4850df428	1	2024-04-05
63323-614-55	ML - Milliliter	63323-614	4731af4b-bba4-440b-8a07-b942a4bcabe4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
Hydralazine Hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2

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 20 · 390 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	51c293c1-70e7-48c7-8af1-a8b74312ed56	2026-09-08	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6c40d818-77a9-492c-b9b6-d8a0fe8d6736	2026-08-27	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
KUGIG ALOE FOAMING INTIMATE WASH	INTIMATE CLEANSING FOAM	Hong Kong KangXing Centennial Management Limited	59f4d398-1186-a168-e063-6294a90ab44b	2026-08-26	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	REMEDYREPACK INC.	5dd5d148-6e23-41de-bff5-551b2aea9598	2026-08-24	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Rohto Optic Glow	NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff	2026-08-20	Warnings	Exact identifier unii: 6DC9Q167V3
Rohto Preservative Free Dry Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	f4b1974c-2412-45f6-b79d-88b8a0bcb608	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
Rohto Dry-Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	8ea5c6c9-48f4-406a-a2cb-9280c546d87d	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
BM BM63 DROPS	CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN	BM Private Limited	59006d82-610a-2e08-e063-6394a90af1ed	2026-08-14	Warnings	Exact identifier unii: 059QF0KO0R
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: ANDA040388 ndc (package): 70518-3659-0 ndc (package): 70518-3659-2 ndc (package): 70518-3659-1 ndc (product): 70518-3659 rxcui: 966571 spl id: 5905ae5e-7ec3-d680-e063-6294a90aa154 spl set id: dca82025-a4cd-4856-aa19-bdf091bf8973 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d2d98842-ff32-4a61-94e0-60e06919948f	2026-08-14	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	8936f66f-10fe-44ab-a26e-dd8b05dfa997	2026-08-10	Warnings	Exact identifier unii: 6DC9Q167V3
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	23b3515f-fbe5-4398-b2df-8b2eccdd01e2	2026-08-10	Warnings	Exact identifier unii: 6DC9Q167V3
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	58773e8c-b6bc-6bc6-e063-6294a90adc26	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Sterile Water	WATER	Cardinal Health 107, LLC	48d75a7c-8329-48a8-bea0-a8c144ddf637	2026-08-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ct	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CARDINAL HEALTH 110, LLC. DBA LEADER	8df69f2c-40c4-245c-e053-2a95a90a5406	2026-08-05	Warnings	Exact identifier unii: 6DC9Q167V3
Garzulys	INSULIN ASPART-FSAN	Meitheal Pharmaceuticals Inc.	30c64769-d2f7-4604-ac9e-2a6bc09506c9	2026-07-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2026-07-30	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
DECONIMO Reconstitution	DECONIMO RECONSTITUTION	Image Amazon LLC	57ab9b1c-9a18-3786-e063-6394a90a2c63	2026-07-28	Warnings	Exact identifier unii: 059QF0KO0R
Neutraflush	EYEWASH STATION ADDITIVE CONCENTRATE	Aero Healthcare	1d9ff2ef-9c9b-f367-e063-6294a90afa0e	2026-07-24	Warnings	Exact identifier unii: 6DC9Q167V3
Sterile Water	WATER	Cardinal Health 107, LLC	9655cd02-82b5-4a75-813b-854b19551481	2026-07-21	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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