NDC 68084-447-11 - 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: 68084-447
Requested NDC: 68084-447-11
Package NDCs from labels: 68084-447-11, 68084-447-01
Manufacturer: Cardinal Health 107, LLC
Effective date: 2024-05-01
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 - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - American Health Packaging	American Health Packaging	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-447	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	12	Legacy NDC	20240316_53908945-540f-4d34-8f0a-b4a87676634e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-447-01	EA - Each	68084-447	9320ca24-9435-4d49-a682-2fdfde635c96	1	2012-07-24
68084-447-11	EA - Each	68084-447	98b80ea1-7164-4905-9c5f-8b8ac84db1aa	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 TABLET [AMERICAN HEALTH PACKAGING]	4
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	3

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 5 of 114 · 2,273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GlowBiotics Tinted Sunscreen SPF 30	ZINC OXIDE	Rum Brands, LLC	544dba29-4785-4ab6-e063-6394a90a17b3	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe Prime and Defend	ZINC OXIDE SUNSCREEN	Societe Clinical Skincare	5439bd31-5ee1-9bca-e063-6394a90a748c	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe CoverShield Tinted SPF	ZINC OXIDE	Societe Clinical Skincare	545efbc4-82d4-f126-e063-6294a90a9710	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier unii: 15FIX9V2JP
SFL SUNSCREEN - SOL DEFENSE SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Lifeline Medical, Inc	5438c185-31c9-c51e-e063-6394a90ae9ef	2026-06-14	Warnings	Exact identifier unii: 15FIX9V2JP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d61ffa06-8138-4a1d-9530-095a80d9c9ce	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a70d20d6-23f0-477e-915c-678a86782175	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen	ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE	IT COSMETICS, LLC	f2990320-b61d-40b8-ba79-18d6b37e7f52	2026-06-11	Warnings	Exact identifier unii: 15FIX9V2JP
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier unii: T5L8T28FGP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	0d65e146-83e5-427f-ac06-04c0d8e72cea	2026-06-09	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d76b02-442e-7a5d-e063-6394a90ae1b3	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d9d689-4a86-5b9c-e063-6394a90aef18	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen	TITANIUM DIOXIDE	ISDIN Corp.	293a1116-e8a2-495f-83db-20dd82ed13c2	2026-06-08	Warnings	Exact identifier unii: 15FIX9V2JP
Eryfotona Actinica Tinted	TITANIUM DIOXIDE	ISDIN Corp.	97357703-0e93-4216-bd1b-a9b202781959	2026-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	08671d39-3be2-d666-e063-6294a90a6207	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden Hour	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	c2398820-f003-707f-e053-2a95a90a6929	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Episciences, Inc.	3d1e2921-cba9-4446-e054-00144ff8d46c	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	2026-06-03	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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