FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
67046-280
11-digit product format
670460280
Labeler code
67046
Product ID
67046-280_7e2b672c-705f-8ef1-e053-2991aa0a1af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA086242
Marketing category
ANDA
Marketing start
2017-10-02
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-280-072022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-142022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-152022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-202022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-212022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-282022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-302022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
67046-280-602022-01-28C16284748780-1d6a99b39-4fcf-a426-e053-dadaa90af4c2270 Hydralazine 25 mg 280 Hydralazine 50 mg HYDRALAZINE HYDROCHLORIDE TABLETS, USP These highlights do not include all the information needed to use Hydralazine Hydrochloride safely and effectively. See full prescribing information for Hydralazine Hydrochloride Hydralazine Hydrochloride (Hydralazine Hydrochloride) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-280-07Hydralazine Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED72
67046-280-14Hydralazine Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED142
67046-280-15Hydralazine Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152
67046-280-20Hydralazine Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED202
67046-280-21Hydralazine Hydrochloride21 in 1 BLISTER PACKTABLET, FILM COATED212
67046-280-28Hydralazine Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED282
67046-280-30Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302
67046-280-60Hydralazine Hydrochloride60 in 1 BLISTER PACKTABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-280HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181230_5a939fe6-46b8-afcc-e053-2a91aa0a663a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN5a939fe6-46b8-afcc-e053-2a91aa0a663a2
905395hydrALAZINE HCl 50 MG Oral TabletPSN5a939fe6-46b8-afcc-e053-2a91aa0a663a2
905225hydralazine hydrochloride 25 MG Oral TabletSCD5a939fe6-46b8-afcc-e053-2a91aa0a663a2
905395hydralazine hydrochloride 50 MG Oral TabletSCD5a939fe6-46b8-afcc-e053-2a91aa0a663a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-280-07670460280077 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-07) 2017-10-020000-00-00NoNoCurrent
67046-280-146704602801414 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-14) 2017-10-020000-00-00NoNoCurrent
67046-280-156704602801515 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-15) 2017-10-020000-00-00NoNoCurrent
67046-280-206704602802020 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-20) 2017-10-020000-00-00NoNoCurrent
67046-280-216704602802121 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-21) 2017-10-020000-00-00NoNoCurrent
67046-280-286704602802828 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-28) 2017-10-020000-00-00NoNoCurrent
67046-280-306704602803030 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-30) 2017-10-020000-00-00NoNoCurrent
67046-280-606704602806060 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-60) 2017-10-020000-00-00NoNoCurrent