NDC 67787-311-01 - 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: 67787-311
Requested NDC: 67787-311-01
Package NDCs from labels: 67787-311-01, 67787-311-10
Manufacturer: InvaGen Pharmaceuticals, Inc.,
Effective date: 2008-12-22
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 - InvaGen Pharmaceuticals, Inc.,	InvaGen Pharmaceuticals, Inc.,	2008-12-22	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67787-311-01	HydrALAZINE Hydrochloride	100 in 1 BOTTLE	TABLET	100		1
67787-311-10	HydrALAZINE Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67787-311	HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1	2 package rows	20090105_d8c6a541-1e02-48c9-92f2-cc850a0c12da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydralazine Hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
FD&C Yellow # 6	INACTIVE INGREDIENT		HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
Lactose anhydrous	INACTIVE INGREDIENT		HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
Microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
Sodium starch glycolate	INACTIVE INGREDIENT		HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]	1

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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b61d1b0-c699-67a8-e054-00144ff88e88	2024-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 905199
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4b7d3378-86f8-0a5f-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 905395
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	37ba0233-ed75-498a-a067-6220da573653	2024-05-24	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	a456bc34-0c79-44f4-9119-50028a978f5f	2024-05-14	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c2638ae6-a210-490f-8389-bbed6a3229c5	2024-04-03	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	8224aa3d-b1b9-40df-93fd-a91c6a158898	2024-02-20	Warnings, Adverse reactions	Exact identifier rxcui: 905225
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	bc37cf50-b18d-467e-bf67-3270faa8332e	2024-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d5b0165e-9823-470a-8ed0-5c4c8722369d	2024-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 905395
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4d1594dc-376b-44bd-8c0e-5de731dfb7f9	2024-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 905199
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	18dd864f-1e27-4c98-8f21-eaded77a3ed6	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905395
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d4b15e-1407-4783-94e4-9971dea68221	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905199
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	36499d4b-bcaf-4b49-aa2a-10c3e34550d0	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905225
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4985994c-23ab-4409-bab6-5a17db767f13	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905199
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	162a0c00-4db8-4f8d-9686-be2f8449abd8	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	914d5b62-6f9b-4665-8562-689367c36230	2023-12-14	Warnings, Adverse reactions	Exact identifier rxcui: 905199
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d4509f69-e60e-4440-957b-5c2714480335	2023-11-27	Warnings, Adverse reactions	Exact identifier rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Exact identifier rxcui: 905395
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	62475f78-5410-43c2-a11d-54a8363c3ae1	2023-07-25	Warnings, Adverse reactions	Exact identifier rxcui: 905395
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	3a7562a8-2f67-4411-ac4a-ab7924193e82	2022-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	149fa857-30ad-451d-b6e2-0000483ccc97	2021-03-12	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222

Reported adverse events (FAERS/openFDA)#

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