Labetalol HCl

Product NDC
63739-366
11-digit product format
637390366
Labeler code
63739
Product ID
63739-366_b3d6d6ba-ed2b-7499-e053-2995a90a7582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA075113
Marketing category
ANDA
Marketing start
1998-08-04
Marketing end
2021-06-30
Substance
LABETALOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-366-102020-07-22C16284748780-1ab0e2407-2b1e-f274-e053-dbdaa90a6471e10796ac-7a39-4985-b5d7-732d939b140f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-366-10EA - Each63739-36681e75279-3e74-4f8e-8887-00d282f7560a12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-366-106373903661010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-366-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-08-232021-06-30NoNoCurrent