FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
HydrALAZINE Hydrochloride - InvaGen Pharmaceuticals, Inc.,InvaGen Pharmaceuticals, Inc.,2008-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67787-311-01HydrALAZINE Hydrochloride100 in 1 BOTTLETABLET1001
67787-311-10HydrALAZINE Hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67787-311HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]12 package rows20090105_d8c6a541-1e02-48c9-92f2-cc850a0c12da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydralazine HydrochlorideACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
HydralazineACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
FD&C Yellow # 6INACTIVE INGREDIENTHYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
Lactose anhydrousINACTIVE INGREDIENTHYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
Microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
Sodium starch glycolateINACTIVE INGREDIENTHYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,]1
Stearic acidINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE 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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.500b7f76-5f4e-4e7d-85c3-18b9f66d75042021-03-04Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEExelan Pharmaceuticals Inc.811831f9-a844-463a-874d-fb8407659f0b2020-09-04Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP63f388e0-9f3d-4902-990c-9a105aa098ad2020-09-01Warnings, Adverse reactionsExact identifier
rxcui: 905225
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LPdfd60a79-2a30-41e6-b000-a144730099a82019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 905395
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP48cf71dd-19dc-4239-9117-ebcf9731a45d2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 905199
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAscend Laboratories, LLCe7bfec3d-5222-4a26-8f99-6c2a28e14aa62017-12-28Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbfbd5960-ae6b-46f5-adfa-e330d7a21dfa2017-12-21Warnings, Adverse reactionsExact identifier
rxcui: 905225
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsExact identifier
rxcui: 905222
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd9892176-d4a6-4edb-92b9-5f56243f3d222016-06-13Warnings, Adverse reactionsExact identifier
rxcui: 905222
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ddbbdb09-3202-42d7-bbb0-08331dde2f542016-02-29Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
D668A6F7-F85D-AEA6-45EF-C0FA8AE3AFF0d8c6a541-1e02-48c9-92f2-cc850a0c12da2008-12-22Warnings, Adverse reactionsExact identifier
spl id: D668A6F7-F85D-AEA6-45EF-C0FA8AE3AFF0
spl set id: d8c6a541-1e02-48c9-92f2-cc850a0c12da

Reported adverse events (FAERS/openFDA)#

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