HydrALAZINE Hydrochloride

Product NDC
63739-328
11-digit product format
637390328
Labeler code
63739
Product ID
63739-328_bfe0e63a-db67-34fd-e053-2995a90ad344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA200770
Marketing category
ANDA
Marketing start
2013-06-30
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-328-102020-07-22C16284748780-1ab0e2407-3277-f274-e053-dbdaa90a6471faaf3493-8318-48b3-b59c-03537880744b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-328-10EA - Each63739-3284696755a-9bb4-4701-8ea4-21dcd1176e1812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-328HYDRALAZINE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]6Legacy NDC20241228_faaf3493-8318-48b3-b59c-03537880744b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-328-106373903281010 BLISTER PACK in 1 CASE (63739-328-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-010000-00-00NoNoCurrent