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 7 of 114 · 2,273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	20efd5fa-3077-4fd4-82d0-ddca946e4528	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
REFRESH LACRI-LUBE	MINERAL OIL, PETROLATUM	Allergan, Inc.	d232a44b-516d-4cdf-a4e7-c3a9a50dc7af	2026-05-15	Warnings	Exact identifier unii: T5L8T28FGP
MELAO Hydrating Lightweight Sunscreen	OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	51c353cb-94c4-e110-e063-6394a90a497e	2026-05-14	Warnings	Exact identifier unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Bella Medical Products LLC	518f69fc-fd39-8195-e063-6294a90a3fdd	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen	RADICAL RESCUE SPF 30 MINERAL SUNSCREEN	ProTransit, Inc.	38e0139c-bb87-55ba-e063-6294a90a82ee	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
EELHOE Sunscreen	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5196ccb0-4515-7e40-e063-6394a90a09bd	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	438479d0-ff61-4008-a0fc-1ee44b97cf7f	2026-05-07	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bb65c8d7-318f-4d52-9d74-ca22ce389638	2026-05-07	Warnings	Exact identifier unii: 15FIX9V2JP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	f0db9c3c-d841-46f9-8409-9ffca83d7a97	2026-05-06	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	67b90f00-4c82-40cd-af96-f8dedf95f8af	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7a2bd17d-0ea7-4326-9939-a747869c01d2	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a396c0eb-f91f-4732-9c20-6b25aa0634b7	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	18b21fba-f6ee-4ac5-a536-096716f51da0	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	13c34bba-f939-4aa7-9457-9d6025902e06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d12905b6-97aa-429a-8800-23856fe31f06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	43599d17-81f4-4c6e-b6bd-d1e700b668ee	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	116f09db-f859-40c5-8857-33503903ee76	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	480e5bf9-8e24-4335-a434-93255ceb640e	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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