HydrALAZINE Hydrochloride

Product NDC
63739-327
11-digit product format
637390327
Labeler code
63739
Product ID
63739-327_bfcac2ac-49e2-4462-e053-2995a90ab2a7
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
25 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
63739-327-102020-07-22C16284748780-1ab0e2407-2c01-f274-e053-dbdaa90a6471b9117e55-9fd0-4ba2-94b4-f5f8c522d70c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-327-10EA - Each63739-32731b61cc9-f041-48af-8c41-1d7e13dae52c12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-327HYDRALAZINE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]6Legacy NDC20241228_b9117e55-9fd0-4ba2-94b4-f5f8c522d70c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-327-106373903271010 BLISTER PACK in 1 CASE (63739-327-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-010000-00-00NoNoCurrent